QC Manager, Stability Program - Remote
Proclinical is currently recruiting for a Quality Control Manager of Stability Program with a leading biotechnology company located remotely. As the Stability Program Quality Control Manager, you will be responsible for managing the stability program in compliance with internal SOPs and ICH guidelines.
- 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.
- Manage and ensure timely completion of stability timepoint pulls as per relevant protocols and stability program SOPs. Manage stability sample inventory and related metrics for current stability studies.
- 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.
- Work closely with Manufacturing, Quality Control, Quality Assurance and Regulatory staff to resolve quality issues.
- Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
- Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).
Skills and Requirements:
- BS in a Life Sciences discipline or equivalent experience is a minimum requirement plus 5 or more years of relevant experience and 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.
- 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 in writing SOPs, stability protocols and reports as well as annual product performance reports.
- Experience with LIMS, Qumas (or similar), and statistical software (.JMP) is preferred.
- Broad experience with biochemistry, biological and microbiological assay support, as well as generating/reviewing the documentation that supports such work.
- Ability to succeed in a team-oriented environment under very dynamic conditions.
- Experience managing OTLs preferred.
If you are having difficulty in applying or if you have any questions, please contact Sam Barry at email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.