- Receipt and disposition of incoming materials.
- Review batch-related documentation, and ensures resolution of issues to release product.
- Perform Product Disposition and Lot Closure. Includes commercial and clinical products.
- Oversee the packaging and shipping process; authorize shipment.
- Provide QA oversight and approval of deviations. Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
- Provide QA oversight and approval of CAPAs. Ensures that associated CAPAs are initiated and resolved, as needed.
- Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved, as needed.
- Support, and as necessary participate in QA on the floor processes, including batch record review.
- Ensure process control measures are in place and followed in product manufacturing.
- Maintain metrics related to batch record review and product disposition in support of the Management Review.
- Generate and update procedures and forms as needed.
- Bachelor’s degree in the biological sciences or related field and minimum of 7 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Good interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities