The position will perform QA work responsibilities in support of manufacturing and facility operations, including quality systems and projects. Functions include proactive support of change control assessments, documentation reviews, discrepancy identification and resolution on the 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 and author annual product reviews.
- Participates in the review and revision of Compliance-related controlled documents.
- Prefer a Bachelor’s degree in a scientific discipline or equivalent.
- Minimum of 5-8 years’ experience in a Quality Assurance role in the pharmaceutical/biotech industry.
- CQA highly desirable.
Competitive salary, bonus, relocation and benefits are offered.
