Senior Quality Officer/Specialist
Description de l'emploi
The SCES Q Contract Manufacturing Quality Specialist acts as the day-to-day liaison with internal
and external customers for quality related activities.
Ensure GMP compliance of the 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 meet our client 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 in a Quality role
- Excellent communication and organizational skills.
- Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first