Quality Assurance Operations Specialist
2 weeks ago
Position Overview:
We are looking for a Senior Quality Operations Specialist to oversee Product Disposition. This role is crucial in participating in Quality initiatives to guarantee adherence to relevant quality standards and regulatory obligations.
Work Schedule:
This position operates on a Day Shift, including weekends, and necessitates an onsite presence.
Essential Qualifications:
- Master's Degree with 5+ years of experience in a GMP setting OR Bachelor's Degree with 7+ years of experience in a GMP environment OR High School Diploma with 11+ years of experience in a GMP context.
Desirable Qualifications:
- Bachelor's degree in biological sciences or a related discipline with at least 7 years of progressive experience in pharmaceutical, biotech, or biologics operations, or equivalent education/work experience.
- Proficient understanding and application of GMPs in accordance with U.S. and EU regulations.
- Ability to interpret and apply procedural and regulatory guidelines in complex situations.
- Capability to assess risk and make phase-appropriate decisions.
- Strong negotiation skills and ability to foster collaboration among team members.
- Excellent interpersonal and communication skills.
- Robust analytical abilities.
- Comfortable working in a dynamic small company environment with minimal supervision.
- Adaptability to shifting priorities and workload.
Key Responsibilities:
- Conduct Product Disposition and Lot Closure for both commercial and clinical products.
- Review batch-related documentation to ensure issues are resolved for product release.
- Examine batch-related shipment documentation to maintain product control during shipment.
- Provide Quality Assurance oversight and review of deviations associated with lots, ensuring timely initiation, investigation, and resolution.
- Oversee and approve CAPAs, ensuring proper initiation and resolution.
- Manage and approve change records, ensuring they are initiated and resolved appropriately.
- Support and engage in investigations, including batch record reviews.
- Ensure that process control measures are implemented and adhered to during product manufacturing.
- Maintain metrics related to product disposition for Management Review.
- Generate and update procedures, forms, and documentation as needed.
- Manage and provide QA oversight for additional processes, including training, inventory management, and new product introductions.
- Compile and report data for management review.
- Maintain production schedules and team timelines.
- Represent Disposition or QA Operations in scheduling meetings.
- Provide QA representation in project discussions and team meetings.
- Support and participate in inspections and audits.
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