Quality Control Specialist

• Review and approve Master Batch Records and ensure conformance to all applicable policies/procedure and compliance with all governing regulations.
• Manage routine and complex deviations.
• Support process and analytical change requests.
• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine.
• Support routine process validation; review and approve validation reports/tech transfer.
• Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.
• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.
• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.

Required Skills:

• Solves complex problems; takes a new perspective using existing solutions.
• Works independently, receives minimal guidance.
• Acts as a resource for colleagues with less experience within their own discipline; can provide minimal guidance on issue resolution and act as SME.
• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.
• Explains difficult issues and works to build alignment around a complex situation.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
• Strong knowledge of External Manufacturing management, supply chain, and operations.
• Fluent in English and good German language skills (Initial Master Batch Record Reviews will be in German).

Nice to haves:

• Direct experience with managing external partners.
• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines.
• Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs).
• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.