QA Specialist I

Job Description :

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.