Pace Analytical Services LLC

Scientist II - Quality Assurance Specialist role, non laboratory role working in an office setting (desk role) reviewing and supporting Scientists work from the Analytical Chemistry department. Pace Analytical Life Sciences (PLS) in Norristown, PA is an industry leading contract lab supplying, formulation development, clinical trial manufacturing and analytical chemistry services to the Pharmaceutical, and Life Sciences industry. This position would be at Pace Analytical Life Sciences in Norristown, PA. This is a full-time, day shift, permanent position. Summary: Employees are exposed to a varied and challenging range of product development projects in a dynamic, fast-paced, rewarding, work environment, with state of the art equipment. Primary Responsibilities: Review and approve analytical documentation in accordance with company policies and current Good Manufacturing Practices (cGMP's) Review documentation to support the analytical chemistry department in accordance with company policies and current Good Manufacturing Practices (cGMP's) including but not limited to: dissolution, HPLC and other analytical chemistry techniques Review laboratory or quality control data pertinent to approved analytical monographs, validation protocols and/or applicable USP test methods Prepare, review, approve and implement Standard Operating Procedures (SOP's) Initiate proper change control, deviation, out of specification and investigation documentation when required Update pertinent logs and tracking systems as they relate to the company's Manufacturing and Quality Systems Report any critical issues to appropriate management in a timely manner To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education and Experience: Bachelor's degree in chemistry or a closely related field; AND 5 years of chemistry experience, including experience with complex programs or operations; OR an equivalent combination of education, training and experience. Required Knowledge and Skills Minimum of 5 years' experience working as an Analytical Chemist/Scientist in a pharmaceutical environment; prior QA or Peer Review experience strongly preferred Previous experience with solid dosage formulations including a thorough understanding of analytical testing and validation methodologies is required HPLC experience required Previous experience working with Phase I and Phase II development preferred Proficient in Microsoft Word and Excel and/or other office or computer applications as required Must be a motivated, well-organized individual with the proven ability to multi task Possess strong attention to detail and can effectively communicate information to appropriate parties through verbal and written communication Ability to work individually or as a team while possessing strong interpersonal skills Have knowledge of various regulatory systems and guidelines (SOP's, cGMP's, IPEC, etc.) Have the desire to work in a small entrepreneurial environment Other duties as assigned. Physical/Mental Requirements: The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone. Working Environment: Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting. OFCCP Statement Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity. First shift Monday through Friday role. From time to time the need to come in early, stay late, and occasional weekend work.