This is a permanent position.
The Supervisor of the QC Data Monitoring and Reporting group will be responsible for oversight of activities related to product release trending in support of the company’s quality program for drug substance, formulated drug substance, and drug products. In addition, the Supervisor will be responsible for oversight of activities related to CofA generation in support of batch release.
• Lead the implementation and maintenance of product release data trending programs for each product candidate.
• Trend product release, reference standard and non product reference standard data to ensure continued integrity of QC results for manufactured products.
• Coordinate and help establish priorities within QC for testing and review of product release material in support of batch release and disposition.
• Coordinate with members of PAS, Manufacturing, QA, and outside partners to provide trending analyses of release data from multiple products.
• Assign work to team members, distribute work load and monitor progress.
• Oversee the generation of Certificates of Analysis (CofA) and Summaries of Analysis (SofA) for all lot release materials. Participate as needed.
• Work with members of Manufacturing, Quality Assurance, Regulatory Affairs, and Project Management to provide updates/status of CofAs, SofAs, trend reports, potential lot release issues, etc.
• Work with the LIMS group to enhance data monitoring practices.
• Review and approve QC SOPs and practices as needed.
• Attend meetings to keep informed of development and manufacturing priorities and activities.
• Compile data to support QC department metrics and performance tracking.
• Assist with the improvement effort of streamlining the product release process.
• Ensure compliance with applicable cGMP regulations and SOPs.
• Perform personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations.
• Requires BS/BA in Life Sciences or related field.
• 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
• Relevant experience may be considered in lieu of educational requirement.
• 2+ years previous supervisory/leadership experience required.
• Strong background in statistical analysis is required.
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