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