Regeneron Pharmaceuticals Biotech Production Compliance Coordinator II in Rensselaer, New York
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:
Level II: · 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.
Level III: Bachelor’s degree, preferably in Life Sciences or a related field plus 2 years experience, or
· AS/AAS Degree in Biotechnology/Biological Science and 4 years of relevant work experience.
· Relevant biotech or pharmaceutical industry experience may be substituted in lieu of educational requirement.
Leveling will be decided during an interview process.
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