Central Admixture Pharmacy
Allentown, Pennsylvania
Company: Central Admixture Pharmacy Job Posting Location: Allentown (6845 Snowdrift Rd), Pennsylvania, United States Functional Area: Quality Working Model: Onsite Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 7098 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS . Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution. CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution. Position Summary: Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections. Essential Duties/Responsibilities: Perform product inspection for defects, leaks and particulates. Perform environmental monitoring of personnel (as needed) and complete documentation. Assist in the media fill process validations to include inspection of filled units Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets: Verify that raw materials meet specification Verify and account for labeling Review temperature and BMS alarms Verify that product test results meet specification limits Verify that all documentation is complete Document non-compliance and work with supervisor/lead if further investigation is needed Submit samples to the appropriate lab for particulate identification or microbial analysis. Assist with equipment calibration program and maintenance record files. Assist with raw material release and movement. Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations. Support internal & external audits. Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.). Participate in Quality Manager's staff meetings Expertise: Knowledge & Skills Knowledge of pharmacy operations and regulatory guidelines. Ability to perform calculations. Ability to work within established procedures and practices Strong organizational skills and attention to detail Ability to effectively troubleshoot issues. Qualifications - Experience/Training/Education/Certification/Etc: Required: Minimum of High School Diploma/GED with work experience Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science. Schedule (2nd shift) Monday-Friday 2:30-11:00PM Salary range is $20.39-$25.49/hr Desired: Experienced in aseptic operations. Experience within a regulated environment Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy. Experience with Process Control, AQL, GMP and GDP While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds. Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands: The employee must occasionally lift and/or move up to 45 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at . Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here . All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Compensation details: 20.39-25.49 Hourly Wage PI4e141d5f5-
12/06/2025
Full time
Company: Central Admixture Pharmacy Job Posting Location: Allentown (6845 Snowdrift Rd), Pennsylvania, United States Functional Area: Quality Working Model: Onsite Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 7098 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS . Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution. CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution. Position Summary: Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections. Essential Duties/Responsibilities: Perform product inspection for defects, leaks and particulates. Perform environmental monitoring of personnel (as needed) and complete documentation. Assist in the media fill process validations to include inspection of filled units Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets: Verify that raw materials meet specification Verify and account for labeling Review temperature and BMS alarms Verify that product test results meet specification limits Verify that all documentation is complete Document non-compliance and work with supervisor/lead if further investigation is needed Submit samples to the appropriate lab for particulate identification or microbial analysis. Assist with equipment calibration program and maintenance record files. Assist with raw material release and movement. Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations. Support internal & external audits. Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.). Participate in Quality Manager's staff meetings Expertise: Knowledge & Skills Knowledge of pharmacy operations and regulatory guidelines. Ability to perform calculations. Ability to work within established procedures and practices Strong organizational skills and attention to detail Ability to effectively troubleshoot issues. Qualifications - Experience/Training/Education/Certification/Etc: Required: Minimum of High School Diploma/GED with work experience Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science. Schedule (2nd shift) Monday-Friday 2:30-11:00PM Salary range is $20.39-$25.49/hr Desired: Experienced in aseptic operations. Experience within a regulated environment Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy. Experience with Process Control, AQL, GMP and GDP While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds. Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands: The employee must occasionally lift and/or move up to 45 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at . Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here . All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Compensation details: 20.39-25.49 Hourly Wage PI4e141d5f5-
Job Title: Manager - QA Microbiology Location: Fairfield, New Jersey Hours / Schedule: Monday-Friday, 7:00 AM-3:00 PM (40 hours/week) Type: Contract Compensation: $32 per hour Position Overview We are seeking an experienced 1st shift QA Microbiology Manager with strong microbiology skills and the ability to lead quality efforts on the production floor. This role supports daytime operations through microbiological testing, analytical checks, and direct oversight of line quality activities. Candidates must bring at least 5+ years of QA/QC experience, advanced microbiology exposure, and the ability to act as a lead resource when production teams require immediate decisions. Strong 1st-shift QA coverage is essential to maintain FDA, HACCP, GMP, and customer compliance as production ramps up across the plant. The site continues to expand output, creating steady needs for microbiology-focused QA talent. Responsibilities Production Line Oversight & Quality Lead start-of-day QA checks and verify operation of metal detectors, X-ray units, and checkweighers Oversee routine line audits including net weights, moisture/salt, blend formulas, labels, closures, and packaging compliance Provide direction to production staff on quality issues during the shift Document and escalate any non-compliant or out-of-spec results Validate product specifications, lot codes, and customer requirements Microbiological & Analytical Testing ("some" hands-on testing) Perform microbiological testing including APC, yeast/mold, and environmental swabbing Conduct analytical tests: pH, moisture/salt, gas levels, and equipment verification Maintain and calibrate microbiology lab instruments and incubators Interpret, document, and communicate microbiological findings Food Safety & Regulatory Compliance Follow and enforce GMP, HACCP, and FDA food safety standards Document deviations, incidents, and QA holds Stop production immediately if unsafe or non-compliant conditions are identified Support daytime investigations and corrective actions Equipment & Recordkeeping Calibrate pH meters, salt meters, moisture analyzers, gas meters, and related QA tools Maintain all QA logs, microbiological data, and equipment documentation Support troubleshooting and preventive maintenance during the shift Requirements 5+ years QA/QC experience in food, dairy, or related manufacturing Strong microbiology background, including APC/yeast-mold testing and environmental monitoring Ability to serve as a manager resource during daytime operations Prior supervisory, lead, manager experience preferred Strong communication, documentation, and problem-solving skills Comfortable in both production and microbiology lab environments Benefits System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref:
12/05/2025
Full time
Job Title: Manager - QA Microbiology Location: Fairfield, New Jersey Hours / Schedule: Monday-Friday, 7:00 AM-3:00 PM (40 hours/week) Type: Contract Compensation: $32 per hour Position Overview We are seeking an experienced 1st shift QA Microbiology Manager with strong microbiology skills and the ability to lead quality efforts on the production floor. This role supports daytime operations through microbiological testing, analytical checks, and direct oversight of line quality activities. Candidates must bring at least 5+ years of QA/QC experience, advanced microbiology exposure, and the ability to act as a lead resource when production teams require immediate decisions. Strong 1st-shift QA coverage is essential to maintain FDA, HACCP, GMP, and customer compliance as production ramps up across the plant. The site continues to expand output, creating steady needs for microbiology-focused QA talent. Responsibilities Production Line Oversight & Quality Lead start-of-day QA checks and verify operation of metal detectors, X-ray units, and checkweighers Oversee routine line audits including net weights, moisture/salt, blend formulas, labels, closures, and packaging compliance Provide direction to production staff on quality issues during the shift Document and escalate any non-compliant or out-of-spec results Validate product specifications, lot codes, and customer requirements Microbiological & Analytical Testing ("some" hands-on testing) Perform microbiological testing including APC, yeast/mold, and environmental swabbing Conduct analytical tests: pH, moisture/salt, gas levels, and equipment verification Maintain and calibrate microbiology lab instruments and incubators Interpret, document, and communicate microbiological findings Food Safety & Regulatory Compliance Follow and enforce GMP, HACCP, and FDA food safety standards Document deviations, incidents, and QA holds Stop production immediately if unsafe or non-compliant conditions are identified Support daytime investigations and corrective actions Equipment & Recordkeeping Calibrate pH meters, salt meters, moisture analyzers, gas meters, and related QA tools Maintain all QA logs, microbiological data, and equipment documentation Support troubleshooting and preventive maintenance during the shift Requirements 5+ years QA/QC experience in food, dairy, or related manufacturing Strong microbiology background, including APC/yeast-mold testing and environmental monitoring Ability to serve as a manager resource during daytime operations Prior supervisory, lead, manager experience preferred Strong communication, documentation, and problem-solving skills Comfortable in both production and microbiology lab environments Benefits System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref:
Title: Senior Quality Assurance Manager Department: Food Safety and Quality Assurance Reports To: VP of Food Safety, Quality & Environmental Safety Position: We seek a transformative Senior Quality Assurance Manager to champion a culture of quality. This role drives operational quality excellence and food safety through visionary leadership, cross-functional collaboration, and a continuous improvement (CI) mindset, leveraging SQF expertise, PCQI certification, and certification management (Halal, Kosher, RSPO, Organic, GFCO) to deliver superior product quality and customer trust. Responsibilities: • Champion Quality Culture: Inspire and lead a transformative quality-focused culture, embedding excellence across all plant operations. • Ensure Food Safety & Compliance: Oversee SQF, HACCP, and FDA compliance, maintaining robust allergen, foreign material, and preventive control programs. • Manage Certifications: Lead compliance for Halal, Kosher, RSPO, Organic, and GFCO certifications, ensuring audit readiness and regulatory adherence. • Drive Continuous Improvement: Partner with cross-functional partners to implement CI initiatives, reduce waste, and eliminate customer complaints via effective root cause analysis (RCA). • Environmental Monitoring Program (EMP): Implement and manage a robust EMP to prevent contamination and ensure compliance. • Lead & Inspire QA Team: Mentor and train staff, fostering accountability and a proactive quality mindset on the plant floor. • Audit Excellence: Prepare for and excel in SQF, Organic, Halal, Kosher, RSPO, and GFCO audits, leveraging PCQI expertise for preventive controls. • KPI & Data Excellence: Develop and track quality metrics using tools like Power BI, Trace Gains to drive actionable improvements. • Build Customer Confidence: Collaborate cross-functionally to resolve complaints and enhance quality processes, ensuring customer satisfaction. Ideal Qualifications: • BS degree in Food Science, Microbiology, or related field; advanced degree a plus. • 10+ years of QA management experience in food manufacturing. • SQF Practitioner and PCQI certification required. • Expertise in managing Halal, Kosher, RSPO, Organic, and GFCO certifications. • Proven leadership with a transformative approach to building a quality-driven culture. • Strong collaboration skills, with experience driving CI initiatives. • Expertise in RCA, HACCP, and regulatory compliance (FDA, USDA). • Proficient in data analysis tools (e.g., Power BI, TraceGains, Excel, Minitab). • Excellent communication skills for engaging customers and stakeholders. Why Join Us: • Supportive and collaborative work culture Equal Employment Opportunity • Ability to adapt to fast-paced environments and manage multiple priorities. • Be part of a mission-driven food company focused on quality and innovation • Competitive salary, benefits, and opportunities for career growth • Commitment to sustainability, food safety, and ethical sourcing All candidates are subject to a criminal background check and standard drug screen. All offers are contingent upon favorable results.
12/04/2025
Full time
Title: Senior Quality Assurance Manager Department: Food Safety and Quality Assurance Reports To: VP of Food Safety, Quality & Environmental Safety Position: We seek a transformative Senior Quality Assurance Manager to champion a culture of quality. This role drives operational quality excellence and food safety through visionary leadership, cross-functional collaboration, and a continuous improvement (CI) mindset, leveraging SQF expertise, PCQI certification, and certification management (Halal, Kosher, RSPO, Organic, GFCO) to deliver superior product quality and customer trust. Responsibilities: • Champion Quality Culture: Inspire and lead a transformative quality-focused culture, embedding excellence across all plant operations. • Ensure Food Safety & Compliance: Oversee SQF, HACCP, and FDA compliance, maintaining robust allergen, foreign material, and preventive control programs. • Manage Certifications: Lead compliance for Halal, Kosher, RSPO, Organic, and GFCO certifications, ensuring audit readiness and regulatory adherence. • Drive Continuous Improvement: Partner with cross-functional partners to implement CI initiatives, reduce waste, and eliminate customer complaints via effective root cause analysis (RCA). • Environmental Monitoring Program (EMP): Implement and manage a robust EMP to prevent contamination and ensure compliance. • Lead & Inspire QA Team: Mentor and train staff, fostering accountability and a proactive quality mindset on the plant floor. • Audit Excellence: Prepare for and excel in SQF, Organic, Halal, Kosher, RSPO, and GFCO audits, leveraging PCQI expertise for preventive controls. • KPI & Data Excellence: Develop and track quality metrics using tools like Power BI, Trace Gains to drive actionable improvements. • Build Customer Confidence: Collaborate cross-functionally to resolve complaints and enhance quality processes, ensuring customer satisfaction. Ideal Qualifications: • BS degree in Food Science, Microbiology, or related field; advanced degree a plus. • 10+ years of QA management experience in food manufacturing. • SQF Practitioner and PCQI certification required. • Expertise in managing Halal, Kosher, RSPO, Organic, and GFCO certifications. • Proven leadership with a transformative approach to building a quality-driven culture. • Strong collaboration skills, with experience driving CI initiatives. • Expertise in RCA, HACCP, and regulatory compliance (FDA, USDA). • Proficient in data analysis tools (e.g., Power BI, TraceGains, Excel, Minitab). • Excellent communication skills for engaging customers and stakeholders. Why Join Us: • Supportive and collaborative work culture Equal Employment Opportunity • Ability to adapt to fast-paced environments and manage multiple priorities. • Be part of a mission-driven food company focused on quality and innovation • Competitive salary, benefits, and opportunities for career growth • Commitment to sustainability, food safety, and ethical sourcing All candidates are subject to a criminal background check and standard drug screen. All offers are contingent upon favorable results.
About Us: We are a fast-growing food manufacturing facility committed to producing safe, high-quality products that meet and exceed regulatory and customer expectations. We are seeking a knowledgeable and experienced Food Safety & Quality Assurance (FSQA) Manager to lead our FSQA programs and ensure ongoing compliance with all food safety standards. Position Summary: The FSQA Manager is responsible for leading all food safety, quality, and regulatory initiatives within the facility. This role oversees FSQA staff, manages compliance programs, prepares for and leads audits, and ensures adherence to all regulatory requirements including USDA, FDA, and third-party audits. The ideal candidate brings strong food manufacturing experience and a proven track record of managing robust food safety systems. Key Responsibilities: Oversee the facility's Food Safety and Quality Assurance programs, including HACCP, GMPs, sanitation, and preventive controls. Maintain compliance with USDA, FDA, and all other applicable regulatory agencies. Lead preparation for and execution of all internal and external audits, including: SQF audits SSOP verification Customer audits Ensure accurate, organized documentation of all food safety systems, including monitoring, verification, and validation activities. Train employees on food safety practices, GMPs, and quality standards. Conduct root-cause analyses, implement corrective and preventive actions, and drive continuous improvement. Work cross-functionally with Production, Sanitation, Maintenance, and Operations to maintain a culture of food safety. Manage FSQA team performance, scheduling, and development. Qualifications: Bachelor's degree in Food Science, Microbiology, or related field preferred (or equivalent industry experience). Minimum 4 years of experience in a food manufacturing facility FSQA role. Strong working knowledge of USDA-regulated environments; experience with USDA programs, labeling, inspections, and daily verification. Hands-on experience with GMP audits, SQF audits, customer audits, and other third-party certification schemes. In-depth understanding of HACCP, preventive controls, and FSMA requirements. Excellent communication, leadership, and problem-solving skills. Ability to lead and motivate teams while maintaining a positive food safety culture. Why Join Us? Growing organization with opportunities for professional advancement Supportive leadership team Competitive compensation and benefits Commitment to food safety excellence Compensation details: 00 Yearly Salary PIdd79b5-
12/03/2025
Full time
About Us: We are a fast-growing food manufacturing facility committed to producing safe, high-quality products that meet and exceed regulatory and customer expectations. We are seeking a knowledgeable and experienced Food Safety & Quality Assurance (FSQA) Manager to lead our FSQA programs and ensure ongoing compliance with all food safety standards. Position Summary: The FSQA Manager is responsible for leading all food safety, quality, and regulatory initiatives within the facility. This role oversees FSQA staff, manages compliance programs, prepares for and leads audits, and ensures adherence to all regulatory requirements including USDA, FDA, and third-party audits. The ideal candidate brings strong food manufacturing experience and a proven track record of managing robust food safety systems. Key Responsibilities: Oversee the facility's Food Safety and Quality Assurance programs, including HACCP, GMPs, sanitation, and preventive controls. Maintain compliance with USDA, FDA, and all other applicable regulatory agencies. Lead preparation for and execution of all internal and external audits, including: SQF audits SSOP verification Customer audits Ensure accurate, organized documentation of all food safety systems, including monitoring, verification, and validation activities. Train employees on food safety practices, GMPs, and quality standards. Conduct root-cause analyses, implement corrective and preventive actions, and drive continuous improvement. Work cross-functionally with Production, Sanitation, Maintenance, and Operations to maintain a culture of food safety. Manage FSQA team performance, scheduling, and development. Qualifications: Bachelor's degree in Food Science, Microbiology, or related field preferred (or equivalent industry experience). Minimum 4 years of experience in a food manufacturing facility FSQA role. Strong working knowledge of USDA-regulated environments; experience with USDA programs, labeling, inspections, and daily verification. Hands-on experience with GMP audits, SQF audits, customer audits, and other third-party certification schemes. In-depth understanding of HACCP, preventive controls, and FSMA requirements. Excellent communication, leadership, and problem-solving skills. Ability to lead and motivate teams while maintaining a positive food safety culture. Why Join Us? Growing organization with opportunities for professional advancement Supportive leadership team Competitive compensation and benefits Commitment to food safety excellence Compensation details: 00 Yearly Salary PIdd79b5-
Description Summary: Performs all lab assistant procedures (including, but not limited to, phlebotomy, client processing, and client services representative functions) and oversees such staff under the guidelines and supervision of the assigned Leader to assure appropriate patient care is met. Responsible for monitoring, rotating stock, or requesting general laboratory and phlebotomy supplies as needed. Assists in specimen processing/handling, collection, and designated testing functions in all areas of the lab. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Customer Service / AIDET / Standards of Behavior. Trains and performs competency checklist with all Phlebotomist/ laboratory assistant staff. Monitors the collection report; resolves problems; completes related paperwork and computer functions. Uses centrifuge, prepares and assures serum/blood specimens are acceptable; prepares specimen for referral to outside reference laboratories; dispenses blood products under supervision of medical technologist. Monitoring the collection area continuously during the shift to assure that all specimens are collected within a timely manner and assisting the phlebotomists in obtaining specimens, if necessary. Handling inquiries, questions and problems as they arise, both within the laboratory and between the lab and other departments in the hospital, maintaining a professional image and exhibiting excellent service. Greets all customers, clients, outpatients, and visitors physically or on the telephone; provides accurate, appropriate, and courteous response to technical questions and results inquiry as requested by physicians and nursing personnel. Communicating follow-up information regarding patient care issues or physician related complaints to the appropriate supervisor, manager, charge tech or director. Performs clerical office duties, client processing, and client service representative duties, as assigned/required. Enters orders and cancellations using Hospital LIS. Receives and processes specimens collected and/or add-on tests and distributes them to the appropriate departments. Processes and maintains laboratory records and reports; monitors chart print rounds for completion and processes reports for Health Information, faxes or mails reports as requested by physicians or clients, processes reference reports, resolves all pending transactions, and maintains printers, copier, and fax machine. Specimen collections are initiated within the appropriate response time. Monitors the collections pending. Reports and resolves problems, completes related paperwork and computer functions. Works as a team member to perform and complete all patient related testing/reporting regardless of individual assignments, to provide timely results on a daily basis. Completes tasks or special projects within the time frame, allowed per any guidelines established as assigned by laboratory supervisory personnel. Inventory control - monitors supply receiving area, distributes supplies, restocks, and processes packing slips; notifies appropriate supervisor/manager when instrument parts, reagents, or supplies are at reorder levels; dates reagents when received and opened according to laboratory policy, and notifies supervisor of expired reagents; completes supply orders, as assigned. Practices safety, infection control, and security as defined by the hospital department and section policy and procedure manuals; follows all safety and infection control procedures including wearing appropriate PPE for assigned job functions; disposes of biohazardous materials and hazardous chemicals as established by departmental policy; all patient information, including lab results, are maintained in the strictest of confidence, limited to health care professionals needing this information to perform patient care. Demonstrates work schedule flexibility by willingly rotating shifts and changing assignments, as required. Job Requirements: Education/Skills Associate of Science Degree preferred. Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases required. Experience 2 years of experience as a Phlebotomist or Laboratory Assistant in a clinical laboratory setting required 5+ years of experience preferred. Licenses, Registrations, or Certifications Medical Laboratory Assistant Certification or Phlebotomist Certification - PBT (ASCP), RPT (AMT), CPT (NPA) or equivalent required. Louisiana requires State Licensure. Work Schedule: 7PM - 7AM Work Type: Full Time
12/02/2025
Full time
Description Summary: Performs all lab assistant procedures (including, but not limited to, phlebotomy, client processing, and client services representative functions) and oversees such staff under the guidelines and supervision of the assigned Leader to assure appropriate patient care is met. Responsible for monitoring, rotating stock, or requesting general laboratory and phlebotomy supplies as needed. Assists in specimen processing/handling, collection, and designated testing functions in all areas of the lab. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Customer Service / AIDET / Standards of Behavior. Trains and performs competency checklist with all Phlebotomist/ laboratory assistant staff. Monitors the collection report; resolves problems; completes related paperwork and computer functions. Uses centrifuge, prepares and assures serum/blood specimens are acceptable; prepares specimen for referral to outside reference laboratories; dispenses blood products under supervision of medical technologist. Monitoring the collection area continuously during the shift to assure that all specimens are collected within a timely manner and assisting the phlebotomists in obtaining specimens, if necessary. Handling inquiries, questions and problems as they arise, both within the laboratory and between the lab and other departments in the hospital, maintaining a professional image and exhibiting excellent service. Greets all customers, clients, outpatients, and visitors physically or on the telephone; provides accurate, appropriate, and courteous response to technical questions and results inquiry as requested by physicians and nursing personnel. Communicating follow-up information regarding patient care issues or physician related complaints to the appropriate supervisor, manager, charge tech or director. Performs clerical office duties, client processing, and client service representative duties, as assigned/required. Enters orders and cancellations using Hospital LIS. Receives and processes specimens collected and/or add-on tests and distributes them to the appropriate departments. Processes and maintains laboratory records and reports; monitors chart print rounds for completion and processes reports for Health Information, faxes or mails reports as requested by physicians or clients, processes reference reports, resolves all pending transactions, and maintains printers, copier, and fax machine. Specimen collections are initiated within the appropriate response time. Monitors the collections pending. Reports and resolves problems, completes related paperwork and computer functions. Works as a team member to perform and complete all patient related testing/reporting regardless of individual assignments, to provide timely results on a daily basis. Completes tasks or special projects within the time frame, allowed per any guidelines established as assigned by laboratory supervisory personnel. Inventory control - monitors supply receiving area, distributes supplies, restocks, and processes packing slips; notifies appropriate supervisor/manager when instrument parts, reagents, or supplies are at reorder levels; dates reagents when received and opened according to laboratory policy, and notifies supervisor of expired reagents; completes supply orders, as assigned. Practices safety, infection control, and security as defined by the hospital department and section policy and procedure manuals; follows all safety and infection control procedures including wearing appropriate PPE for assigned job functions; disposes of biohazardous materials and hazardous chemicals as established by departmental policy; all patient information, including lab results, are maintained in the strictest of confidence, limited to health care professionals needing this information to perform patient care. Demonstrates work schedule flexibility by willingly rotating shifts and changing assignments, as required. Job Requirements: Education/Skills Associate of Science Degree preferred. Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases required. Experience 2 years of experience as a Phlebotomist or Laboratory Assistant in a clinical laboratory setting required 5+ years of experience preferred. Licenses, Registrations, or Certifications Medical Laboratory Assistant Certification or Phlebotomist Certification - PBT (ASCP), RPT (AMT), CPT (NPA) or equivalent required. Louisiana requires State Licensure. Work Schedule: 7PM - 7AM Work Type: Full Time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
