Leadstack Inc
Job Description Job Description Job Titles: Calibration Technician III Location: Morrisville, NC - 27560 Duration: 6 months Payrate: $30/hr - $36/hr on W2 Job Description: The Calibration Technician III manages laboratory equipment calibrations, maintenance, and repairs, ensuring compliance with all GxP regulations. This role is responsible for the quality review of documentation and the initiation of deviation investigations related to metrology. Individual works under the supervision and direction of more senior level roles and uses existing procedures to solve routine or standard problems Key Responsibilities: Calibration Execution: o Independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations. o Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices. o Ensures all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP). Safety and Quality Compliance: o Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents. o Maintain training compliance in the Quality Management System. o Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues. o Primary responsibility for the initiation, writing, and support of investigations (Deviations/CAPAs) related to instrument calibration failures or other instrument-related issues. Vendor Management (Metrology): o Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment. o Responsible for the technical review and approval of all equipment calibration and maintenance documentation performed by external parties with a detailed eye for good documentation practices. Asset Induction: o Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners and planner / scheduler. o Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria. Documentation: o Maintains and/or generates SOPs and controlled documents pertaining to the calibration program. o Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS. Team Collaboration: o Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT. Required Qualifications: High School Diploma and 6 years of metrology experience OR Bachelor's Degree and 2 years of metrology experience in the Pharma/Biotech industry. Experience investigating and completing CAPAs and deviations in a GxP environment. Strong understanding of calibration methodology, tolerances, and FDA regulations. If you have any questions, feel free to call me on or send an email on Thanks and Regards Akarsh Yathiraj Senior Recruiter C. D. A.611 Gateway Blvd, Ste 120 South San Francisco, CA 94080W.
Job Description Job Description Job Titles: Calibration Technician III Location: Morrisville, NC - 27560 Duration: 6 months Payrate: $30/hr - $36/hr on W2 Job Description: The Calibration Technician III manages laboratory equipment calibrations, maintenance, and repairs, ensuring compliance with all GxP regulations. This role is responsible for the quality review of documentation and the initiation of deviation investigations related to metrology. Individual works under the supervision and direction of more senior level roles and uses existing procedures to solve routine or standard problems Key Responsibilities: Calibration Execution: o Independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations. o Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices. o Ensures all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP). Safety and Quality Compliance: o Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents. o Maintain training compliance in the Quality Management System. o Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues. o Primary responsibility for the initiation, writing, and support of investigations (Deviations/CAPAs) related to instrument calibration failures or other instrument-related issues. Vendor Management (Metrology): o Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment. o Responsible for the technical review and approval of all equipment calibration and maintenance documentation performed by external parties with a detailed eye for good documentation practices. Asset Induction: o Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners and planner / scheduler. o Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria. Documentation: o Maintains and/or generates SOPs and controlled documents pertaining to the calibration program. o Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS. Team Collaboration: o Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT. Required Qualifications: High School Diploma and 6 years of metrology experience OR Bachelor's Degree and 2 years of metrology experience in the Pharma/Biotech industry. Experience investigating and completing CAPAs and deviations in a GxP environment. Strong understanding of calibration methodology, tolerances, and FDA regulations. If you have any questions, feel free to call me on or send an email on Thanks and Regards Akarsh Yathiraj Senior Recruiter C. D. A.611 Gateway Blvd, Ste 120 South San Francisco, CA 94080W.
Leadstack Inc
Morrisville, North Carolina
Job Description Job Description Job Title: Calibration Technician I Location: Morrisville, NC - 27560 Duration: 6 Months Contract Pay rate: $22/hr - $25/hr on W2 Job description: The Calibration Technician, reporting to the Manager, Calibration & Instrumentation, will support the calibration, maintenance, and repair of laboratory equipment at our RTP locations. The technician will work closely with laboratory staff, equipment owners, Quality, Facilities, Engineering, IT, and external service vendors to help ensure laboratory equipment remains properly maintained, calibrated, and compliant with applicable requirements. Responsibilities Performs routine maintenance, calibration, and basic repairs on laboratory equipment under established procedures and with guidance from experienced technicians or management. Uses the Computerized Maintenance Management System (CMMS) to document, track, and complete equipment maintenance and calibration activities. Coordinates with onsite vendors and service providers to support scheduled maintenance, calibration, and repair activities. Assists with reviewing vendor calibration and maintenance documentation for completeness, accuracy, and compliance with good documentation practices. Supports investigations related to calibration failures, equipment issues, and other instrument-related problems. Assists with the introduction of new laboratory equipment, including helping establish calibration requirements and schedules in coordination with equipment owners and management. Researches equipment operating specifications and assists with identifying appropriate calibration standards and acceptance criteria. Assists with thermal mapping studies for controlled environments to support equipment qualification and performance monitoring. Assists with maintaining and updating SOPs and other controlled documents related to the operation, maintenance, and calibration of laboratory instrumentation and equipment. Supports the review of system documentation, including user requirements and equipment specification documents. Works collaboratively with laboratory staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT on laboratory equipment-related activities. Communicates with equipment manufacturers, vendors, and service providers to obtain technical information and support as needed. Accurately documents calibration, maintenance, and repair activities and enters required information into the CMMS. Reviews completed work and data for accuracy, completeness, and adherence to established procedures. Follows all applicable SOPs, company policies, safety requirements, and technical guidance documents. Performs calibration and thermal mapping activities in accordance with applicable industry standards and regulatory requirements, including USP, NIST, FDA, GLP, and GMP, as applicable. Develops technical knowledge of laboratory instrumentation, calibration practices, maintenance procedures, and applicable regulatory requirements through hands-on experience and training. Escalates equipment issues, calibration failures, documentation concerns, and other technical issues to the appropriate supervisor or experienced technician when additional support is required. Minimum Requirements High School Diploma and 1-3 years of metrology experience OR Bachelor's Degree and 0.5-2 years of metrology experience is required. Experience working in the Pharma/Biotech industry. Understanding of calibration methodology and tolerances. Experience working with loop calibrations. Understanding of FDA and GxP regulations and requirements. Experience working in GMP, GLP environments. Ability to read and interpret instrument technical drawings. Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment. Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills. Excellent verbal and written communication skills. Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team. Preferred Requirements Bachelor's Degree in a relevant field Certified Calibration Technician Experience working in CLIA, and R&D laboratory environments If you have any questions, feel free to call me on or send an email on Thanks and Regards Akarsh Yathiraj Senior Recruiter C. D. A.611 Gateway Blvd, Ste 120 South San Francisco, CA 94080W.
Job Description Job Description Job Title: Calibration Technician I Location: Morrisville, NC - 27560 Duration: 6 Months Contract Pay rate: $22/hr - $25/hr on W2 Job description: The Calibration Technician, reporting to the Manager, Calibration & Instrumentation, will support the calibration, maintenance, and repair of laboratory equipment at our RTP locations. The technician will work closely with laboratory staff, equipment owners, Quality, Facilities, Engineering, IT, and external service vendors to help ensure laboratory equipment remains properly maintained, calibrated, and compliant with applicable requirements. Responsibilities Performs routine maintenance, calibration, and basic repairs on laboratory equipment under established procedures and with guidance from experienced technicians or management. Uses the Computerized Maintenance Management System (CMMS) to document, track, and complete equipment maintenance and calibration activities. Coordinates with onsite vendors and service providers to support scheduled maintenance, calibration, and repair activities. Assists with reviewing vendor calibration and maintenance documentation for completeness, accuracy, and compliance with good documentation practices. Supports investigations related to calibration failures, equipment issues, and other instrument-related problems. Assists with the introduction of new laboratory equipment, including helping establish calibration requirements and schedules in coordination with equipment owners and management. Researches equipment operating specifications and assists with identifying appropriate calibration standards and acceptance criteria. Assists with thermal mapping studies for controlled environments to support equipment qualification and performance monitoring. Assists with maintaining and updating SOPs and other controlled documents related to the operation, maintenance, and calibration of laboratory instrumentation and equipment. Supports the review of system documentation, including user requirements and equipment specification documents. Works collaboratively with laboratory staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT on laboratory equipment-related activities. Communicates with equipment manufacturers, vendors, and service providers to obtain technical information and support as needed. Accurately documents calibration, maintenance, and repair activities and enters required information into the CMMS. Reviews completed work and data for accuracy, completeness, and adherence to established procedures. Follows all applicable SOPs, company policies, safety requirements, and technical guidance documents. Performs calibration and thermal mapping activities in accordance with applicable industry standards and regulatory requirements, including USP, NIST, FDA, GLP, and GMP, as applicable. Develops technical knowledge of laboratory instrumentation, calibration practices, maintenance procedures, and applicable regulatory requirements through hands-on experience and training. Escalates equipment issues, calibration failures, documentation concerns, and other technical issues to the appropriate supervisor or experienced technician when additional support is required. Minimum Requirements High School Diploma and 1-3 years of metrology experience OR Bachelor's Degree and 0.5-2 years of metrology experience is required. Experience working in the Pharma/Biotech industry. Understanding of calibration methodology and tolerances. Experience working with loop calibrations. Understanding of FDA and GxP regulations and requirements. Experience working in GMP, GLP environments. Ability to read and interpret instrument technical drawings. Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment. Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills. Excellent verbal and written communication skills. Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team. Preferred Requirements Bachelor's Degree in a relevant field Certified Calibration Technician Experience working in CLIA, and R&D laboratory environments If you have any questions, feel free to call me on or send an email on Thanks and Regards Akarsh Yathiraj Senior Recruiter C. D. A.611 Gateway Blvd, Ste 120 South San Francisco, CA 94080W.