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QA Validation Specialist

Company Name:
Regeneron
Job Summary and Essential Functions:
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.
Summary:
Responsible for reviewing qualification and validation documents, such as equipment qualification, cleaning validation, and process validation documents.
Essential Duties and Responsibilities include, but are not limited to, the following:
Responsible for Quality Assurance Validation document reviews of equipment and utility qualification, cleaning, SIP, and process validation documents.
Reviews HVAC reports, work order moves, new equipment request; and other documentation as required
Assesses quality system documentation for completeness and accuracy
Resolves problems, identifies issues and determines system improvements
Attend meetings relevant to assigned projects as needed.
Lead special projects as assigned by the Project Manager.
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Experience and Required Skills:
Knowledge and Skills:
Interpersonal, oral, and written communication skills;
Word processing, spreadsheet, database management, statistical analysis, graphing, and presentation programs.
cGMP operations
Education and Experience:
BS/BA in Engineering, Chemistry, or Life Sciences; may substitute relevant experience for education plus 2 years experience within the field of QA, Validation, or Manufacturing

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