We are seeking a Senior Specialist of Quality Operations responsible for Product Disposition. This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
NOTE: Position is Day Shift including weekends and requires onsite presence.
Basic Qualifications • Master's Degree and 5+ years of experience in GMP environment OR Bachelor's Degree and 7+ years of experience in GMP environment OR High School Degree and 11+ years of experience in GMP environment
Preferred 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 • Good interpersonal skills • Strong written communication skills • Strong analytical skills • Comfortable in a fast-paced small company environment and operate with minimal direction • Ability to adjust workload based upon rapidly changing priorities
Responsibilities • 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, etc. • 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