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Sr QA Specialist
4 months ago
Position: Sr QA Specialist - I Location: El Segundo, CA 90245 Duration: 17 Months Job Type: Contract Work Type: Onsite Job Description
- Client is 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.
- 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
- 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
- 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 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
