Job Details: 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
