Biotech Production Compliance Coordinator II
Regeneron Pharmaceuticals Inc

Job Info

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Summary: Performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Performs administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures.

• Reviews completed batch records and logbooks in accordance with cGMP standards to ensure compliance with written procedure.

• Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.

• Monitors production processes to obtain necessary data in support of investigations and track effectiveness of changes.

• Participates in cross-functional study teams to support and/or author investigations.

• Gathers, trends, and analyzes process related data to drive consistency and timeliness.

• Documents all training.

• Assists with training of new employees.

• Ensures all tasks are performed in a manner consistent with safety standards.

Education and Experience:

• Bachelor's degree, preferably in Life Sciences or a related field, or

• AS/AAS Degree in Biotechnology/Biological Science and 2 years of relevant work experience.

• Relevant biotech or pharmaceutical industry experience may be substituted in lieu of educational requirement.

This job has expired.