Upvote
Downvote
Sr. QA Specialist
Share Job
- Suggest Revision
- The Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with BioCryst's Quality Systems in support of small and large molecule drug substance and drug product manufacturing/packaging and testing performed at Contract Manufacturing Organizations (CMOs).
- The Sr. QA Specialist will be responsible for ensuring compliance with BioCryst SOPs and Policies for all outsourced and internal GMP activities.
- This role has high visibility throughout the organization and therefore requires close coordination across multiple groups with-in BioCryst, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, Safety, Supply Chain and Finance.
- Reviews cGMP documentation, including, but not limited to analytical/stability data, deviations, OOS investigations, change controls, master batch records and executed records associated with cell banking, drug substance (API), drug product, packaging, and labeling.
- Experience in early phases of drug development, from non-clinical toxicology studies to registration and process validation.
Active Job
Updated TodaySimilar Job
Relevance
Active