- The Quality Specialist acts as the day-to-day liaison with internal and external customers for quality related activities.
- Ensure GMP compliance of products manufactured and/or tested at a contract facility.
- Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
- Manage quality systems, e.g. change control, deviations, complaints, and product investigations.
- Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product i and GMP requirements.
- Contribute to the completion of milestones associated with specific projects.
- 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
- 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.
- Experience in a cGxP or other regulated environment, to include
- A few years in a Quality role
- Excellent communication and organizational skills.
- Demonstrated ability to perform work requiring attention to detail and of high quality