Sr. Project Manager, Quality Assurance (QA)

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...