Quality Assurance Supervisor, 2nd Shift
at Regeneron Pharmaceuticals in New York NY US
*This is a second shift position
Essential Duties and Responsibilities:
Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions:
- master records
- executed records
- failure investigations
- change control documents
- corrective/preventive action documents
- standard operating procedures
- validation protocols and summary reports
- QC data
- raw material tests
- Approves various documents relating to area function, including those listed above.
- Supervise, provide direction and assign work to QA Specialists to meet goals and timings
- Coordinates prioritization of activities with area management.
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
- Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
- Participates in regulatory and customer activities.
- Collaborates with functional departments to resolve issues.
Education and Experience:
- BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with minimum 4 years experience in a pharmaceutical/biologics manufacturing environment desired. Previous supervisory or leadership experience required.
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