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GMP Quality Assurance Document Control Specialist
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- The GMP Quality Assurance Document Control (QADC) Specialist will primarily be responsible for the Therapeutic Cell Production Core GMP Document Control operations, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, management and filing of controlled documents, and retention of GMP records.
- The QADC Specialist is responsible for reviewing, formatting, publishing, and distributing SOP, PBRs, and other GMP controlled documents through the current paper and electronic systems.
- The GMP QADC Specialist will work closely with Quality Assurance Specialists and assist with internal and external audits and other quality assurance daily work and projects as assigned.
- BA/BS degree in biological sciences or health related field or equivalent
- 1 year academic, biotechnological, or pharmaceutical industry experience in a GMP biologics manufacturing environment.
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