About the Role
Job Responsibilities
Maintain and revise QA related procedures, as needed.
Maintain cGMP training systems and perform on‑site team member training in Quality related matters.
Ensure GxP support and oversight, as applicable, for relevant site functions and activities.
Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring, as required.
Perform QA batch record review and disposition of manufactured early‑phase clinical product batches.
Provide final QA approval of investigations and disposition of any impacted product batches.
Evaluate deviations and propose batch rejections, if applicable.
Perform QA review and approval of the following, as needed:
Environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data.
Investigation of non‑conforming product.
Investigation of out‑of‑specification (OOS) resu...
Maintain and revise QA related procedures, as needed.
Maintain cGMP training systems and perform on‑site team member training in Quality related matters.
Ensure GxP support and oversight, as applicable, for relevant site functions and activities.
Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring, as required.
Perform QA batch record review and disposition of manufactured early‑phase clinical product batches.
Provide final QA approval of investigations and disposition of any impacted product batches.
Evaluate deviations and propose batch rejections, if applicable.
Perform QA review and approval of the following, as needed:
Environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data.
Investigation of non‑conforming product.
Investigation of out‑of‑specification (OOS) resu...
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