QC Manager, Stability Program - Remote

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
Gaithersburg, USA
Posting date: 13 Aug 2020
QA.JL.31256

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.

Job Responsibilities:

  • 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 s.barry@proclinical.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.

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