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Sr. Associate I, Quality Assurance
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Full-time
- The Sr. Quality Assurance Associate I is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.
- Activities include but are not limited to review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management.
- Batch Record Review impacting Product Disposition: Review all Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, etc.)
- Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact.
- Help in implementation of Quality Systems/System Improvements and technical problem solving.
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