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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.