Senior Quality Officer/Specialist

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Description de l'emploi

• Release product in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
• Implement methods and procedures for inspecting, testing, and evaluating the precision and
• accuracy of products and production equipment.
• Compile data and write summaries for periodic product reviews, investigations, complaints, and
• deviations.
• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
• Expert review.
• Interact with multi-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and handle schedule and/or process-related conflicts.
• Demonstrate understanding of applicable US and global regulations related to manufacture of
• medicinal products (small molecules and biologics).
• Monitor contractor performance to established Key Performance Indicators (KPI) and report
• adverse trends.
• Provide guidance to less experienced staff, as applicable.

Profil

• Bachelor’s or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include +3 years in a Quality role
• Excellent communication and organizational skills