External QA Specialist, Downstream CMO OperationsApply Now
Location: Norwood, Massachusetts 02139
Employment Type: Contract
Contract Length: 6+ months
Job Summary: The Sr. Specialist will act in a Lead capacity and will be responsible for building working relationships with external CMO stakeholders (e.g. Chemistry, Manufacturing Science & Technology, Analytical, Quality Control) to perform ongoing quality assurance responsibilities in support of the manufacture, testing, and release of products. He/she will work with the Quality Systems Team to identify and support continuous improvement opportunities.
- Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)
- Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
- Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories
- Support Annual Product Review report generation and approval
- Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
- Support disposition of finished intermediates/drug substances
- MS with a minimum 2-5 years or a BS/BA with a minimum of 5-8 years’ experience in Biotech, Pharma or Clinical Research Organization.
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience working with CROs, vendors, and relationship management preferred.
- Good Manufacturing Practices per 21 CFR Part 210, 211, Eudralex Vol 4.
- Concepts from Analytical Method Development per ICH Q2(R1)/FDA Guidelines
- Quality System Experience: Change Management/Change Controls, Deviations/ investigations, CAPAs, Gap Analysis, Audit Response
- Knowledgeable on Biologic’s Downstream Manufacturing Processes (TFF, Chromatography Columns, and DS Final Fill)
- Experienced with process and method validation
Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.
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