- Collaborate with other departments to ensure data is supplied on time and is complaint with procedures.
- US and Non-US Annual Product Review
- Identify trends in process data that can affect conclusions in technical reports.
- Author SOPs, change control, APRs
- Assure that employees understand industry practices and regulations related to APR
- Complete process improvements and document updates
- Ensure that APRs are done in a timely fashion
- Assist departments in analyzing manufacturing and laboratory data
- Advanced knowledge of Quality Assurance industry practices, systems, principles, and concepts.
- Technical writing skills
- Microsoft Office
- Knowledge of cPK and 21CFR measurements
- Leadership/mentoring experience
- Excellent communication skills