QA work in support of manufacturing and facility operations, including quality systems and projects. Includes support of change control assessments, documentation reviews, discrepancy identification and resolution on the production floor.
- Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations.
- Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents
- Identifies compliance risks and develops sound rationale as basis for audit observations.
- Supports the coordination activities and assists with interactions during regulatory agency inspections
- Perform internal audits, risk assessments and author annual product reviews.
- Participates in the review and revision of Compliance-related controlled documents.
- Bachelor’s degree in a scientific discipline or equivalent required
- Minimum of 5-8 years’ experience in a Quality Assurance role in the pharmaceutical industry required
- CQA preferred
Phone: 860-278-5840 ext 245