To plan, organize, and supervise the activities of auditing, in-process inspection in manufacturing and packaging, and quality assurance administration to ensure regulatory compliance.
- Comprehend, maintain, and promote compliance in a regulated pharmaceutical manufacturing environment, ensuring product integrity, safety, and compliance with standards.
- Plan and supervise the daily activities of the quality assurance operation and inspectors, to ensure work is completed in a timely and accurate manner.
- Train, coach, and mentor QA personnel. Ensure training records are complete and accurate.
- Be proficient in all areas of manufacturing and packaging inspection process, including in-process QA, line inspection, label operation, incoming inspection, and expiration date assignment. Perform these duties as needed and directed by QA Management.
- Review batch records for accuracy and completeness for product disposition. Ensure that corrections are made in a timely manner.
- Possess a working knowledge of statistical based sampling plans and their application.
- Write Exception reports and provide information needed to investigate, document, and close Exceptions. Participate in non-compliance and customer complaint investigations.
- Quarantine and complete documentation for non-conforming materials. Ensure security of components and products in controlled access areas.
- Create and revise SOPs and Work Instructions. Track and trend metrics.
- Perform other duties as required.