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Assurance Assessment Lead
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Full-time
- Location: Lexington, MA (Hybrid - Onsite 3 days a week, 2 days from home)
- Execute risk assessments such as LOPA, HACCP, or FMEA to prioritize GAPs and create a CAPA plan.
- Manage and oversee the CAPA plan, coordinating with stakeholders to ensure timely delivery and resolve any issues.
- At least 5+ years of experience in microbiological/sterilization, specifically in pharmaceutical or biotechnology environments.
- Knowledge of cGMP, ICH, FDA, EU compliance regulations, and USP, EP, JP monographs for microbiology.
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