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Careers > Description Quality Assurance Manager/Auditor

You will be responsible for various areas including QA Documentation Management, QA Operations, Internal Auditing, Quality Review, and Training activities within a dynamic GXP organization. You will also provide Quality support for manufacturing, clinical and non-clinical Corporate Development Programs as well as maintain QA Quality Systems in compliance with Current Good Manufacturing Practices (CGMP).  Additionally, you may also participate in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) oversight of external operations.

Duties and responsibilities

• Implement and manage Proteolix GXP Document Management Systems.
• Write, revise and update SOP’s. 
• Develop, maintain and monitor QA Quality Systems to ensure GXP compliance.
• Organize and present Quality Training Programs for Proteolix  employees.
• Conduct GMP, GCP, or GLP Internal and Contract Operations Audits
• Monitor Change Management, Deviations, OOS/OOT investigations, CAPA programs and prepare reports.
• Manage investigation questions and closure follow-up.
• Review specifications, testing procedures, stability protocols, and SOP changes to ensure compliance with cGMP and other quality policies.
• Review analytical data, documentation, and batch record release packages for technical accuracy, completeness and compliance.
• Review internal and external stability data, prepare stability reports to support regulatory filings.
• Perform Quality technical support and product trouble shooting activities.
• Must be able to travel up to 25% and may be responsible for supervision of support personnel.
• Other duties as assigned.

Requirements:

• B.S. or equivalent with at least five (5) years experience in the Biotech/Pharmaceutical industry.
• Solid understanding of GMPs.
• Previous supervisory/management experience.
• Experience with 21CFR Part 11. 
• Computer validation and database development experience a plus.
• Must possess proven leadership and organizational skills.
• Skilled in technical writing, database management, and records retention.
• Must have experience with GMP Document Change Control, adept at performing audit functions and writing Standard Operating Procedures (SOPs).
• Skilled at motivating and mentoring subordinates, working in a collaborative, team-oriented environment and accurately performing functions in a timely manner.
  

Please send all inquiries to careers@proteolix.com. No agencies please.

Proteolix offers competitive compensation and benefits, equity participation, and an interactive, professional environment that recognizes/rewards achievements. We are proud to be an equal opportunity employer.

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