Perform Product Disposition and Lot Closure. Includes commercial and clinical products.
Review batch-related documentation and ensure resolution of issues to release product.
Review batch-related shipment documentation to ensure product shipment remained in control.
Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
Provide QA oversight and (limited) approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved.
Support and participate in investigations, including batch record review.
Ensure process control measures are in place and followed in product manufacturing.
Maintain metrics related to product disposition in support of the Management Review.
Generate and update procedures, forms and other documents.
As assigned, manage and provide QA oversight for other processes, including training, warehouse/inventory, redose, new product introductions.
Generate and report data for management.
Maintain production (finite), disposition, and team schedules.
Represent Disposition or QA Ops at plant and multi-site scheduling meetings.
Provide QA representation on projects and at team meetings.
Provide QA representation at multi-site disposition meetings.
Support and participate in inspections and audits.
Qualifications:
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 interpret and apply procedural and regulatory guidance in potentially ambiguous situations.
Ability to understand risk and provide phase-appropriate appropriate decisions.
Ability to effectively negotiate and build collaboration amongst individuals.