Biotech Production Compliance Coordinator I-III

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.