The Quality Operations Specialist will ensure compliance with GMP standards, support QA in manufacturing, conduct quality checks, and assist in audits.
Work Schedule
12 hr shift/daysEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Position Summary
Join Thermo Fisher Scientific Inc. as a Quality Ops Specialist for impactful work.
Responsibilities
- Follow site safety requirements and maintain safe working conditions during daily operations.
- Quality on the floor: shop floor QA performer and problem solver.
- Write all quality operational procedures and review SOPs from other functional teams.
- Provide QA support to manufacturing operations and coordinate routine shop floor compliance.
- Collect firsthand shop floor information and collaborate with operations teams to solve problems.
- Perform Quality Monitoring for aseptic manufacturing steps.
- Conduct Acceptable Quality Checks for sterile products.
- Coordinate microbiology quality for vial reading of incubated media-filled vials.
- Support QC area by reviewing QC documents.
- Participate in site operational readiness programs, including self-inspection and data integrity surveillance.
- Review and approve Master Batch Records and Master Formulation Records to ensure compliance with TFS quality standards and cGMP requirements.
- Assist QA manager with batch disposition.
- Review and approve validation documents, including computer system validation.
- Maintain site readiness for GMP and client audits.
- Lead or participate in deviation and OOS investigations to determine root causes and implement effective CAPAs.
- Review and approve relevant procedures to ensure compliance with cGMP and TFS quality standards.
- Support regulatory inspections and client audits to ensure effective management of QA operations areas.
Minimum Requirements/Qualifications
Education:
- Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area with equivalent experience.
Experience:
- 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may also be considered.
- Experience in Quality Management Systems and biologics is an asset.
Proficiencies:
- Knowledge of cGMP, Regulatory Compliance, and GMP Quality Management Systems.
- Strong detailed thinking and communication skills.
- Effective coordination and collaboration abilities.
- Proven problem-solving skills and knowledge of Quality Risk Management tools.
Top Skills
Cgmp
Quality Management Systems
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