Responsibilities
- Management of the documentation related to the review, reconciliation, and release processes.
- Performs QA Review for Batch Record lot release
- Develop, maintain, and report to senior management Quality Metrics for product release
- Supports internal and external audits as needed
- Assist as needed with the quality system processes such as NCR, CAPA
Qualifications
- BA preferred and/or a minimum of 5 years work experience in a regulated environment required
- Experience with medical device and/or IVD manufacturing process qualifications/validations (IQ/OQ/PQ)
- Experience with Document Control Systems
- Prior experience in the Medical Device and/or IVD industry experience highly preferred