Manager / Sr Manager Quality Control

Job description

Within this role you will oversee a team involved in laboratory quality control testing, and has technical responsibility for all aspects of QC testing. A typical day might include, but is not limited to, the following: - Coordinating with members of Manufacturing, Stability, and Business Ops to provide analytical support - Managing QC Analysts, distributes work load, and monitors progress - Managing product testing to ensure efficient and compliant operations - Ensuring QC Analysts receive proper training - Attending meetings to keep informed of manufacturing priorities - Ensuring that safety standards are maintained - Ensuring compliance with applicable cGMP regulations and SOPs - Investigating a typical and OOS test results as necessary - Managing transfers internally from R&D to the QC laboratory or from PAS to the QC Laboratory - Managing transfers externally from QC laboratory to contract labs, includes audits if needed - Managing QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness - Tracking and monitoring the timeline of analytical validation projects - Monitoring the team performance for Compli...