Quality Control Manager (Stability Program)

Our client a biopharmaceutical company is looking to add a Quality Control Manager to their stability program team!Job Title: QC Manager (Stability Program)Location: Gaithersburg, Maryland (Hybrid model 2-3 days on-site)Type: DirectResponsibilities

Oversight and maintenance of the stability program and related stability studies.

Oversight and generation of stability SOPs, protocols, and reports (interim / final). Revise stability protocols, reports and SOPs as needed.

Oversite and management of CMO/OTLs executing current stability protocols.

Generate and present metrics for QC Stability in support of Management Review and investigations. Oversight and support stability sample shipments to contract laboratories and/or sample storage vendors.

Perform stability data trending in accordance with stability program SOPs and ICH guidelines. Perform QC testing and data review as needed to support product release and stability studies.

Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.

Requirements

Bachelor in a Life Sciences discipline or equivalent experience,2 years of management experience in GMP regulated laboratory preferred.

Considerable knowledge/expertise relevant to Stability Program, ICH guidelines, QC methods used for protein chemistry, molecular biology, and microbiological testing.

Strong Biostatistics background for Evaluating Stability data per ICH Guideline Q1E

Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.

Experience with LIMS, Qumas (or similar), and statistical software (.JMP) is preferred.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.