QA Specialist I - III 2nd Shift
at Regeneron Pharmaceuticals in New York NY US
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Determines disposition of final product and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
This is a 2nd shift position
Essential Duties and Responsibilities include:
- Prepares appropriate documentation and executes release of acceptable product lots and vendor materials.
- Reviews completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits, and approves change control and SOPs.
- Reviews, edits, and approves new and revised master manufacturing records.
- Reviews, edits, and approves validation protocols and executed protocol reports.
- Audits production and other departments for quality system effectiveness.
- Performs hands-on monitoring of production and non-production activities and notifies area and Quality Management of any observed non-compliance.
- Performs AQL vial inspections.
Education and Experience:
- Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience.
To apply for this position, please CLICK HERE
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