**Work Schedule** Rotational shift days **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Job Description** The Quality Operation Specialist is responsible for the execution of quality compliance relevant activities that maintain GMP compliance in shopfloor, engineering and warehouse through appropriate vigilant and guidance from QA Manager, ensuring site compliance with GMP requirement and corporate policies and procedures is maintained. Join Thermo Fisher Scientific Inc. as a QA Sterility Assurance 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:** + 2-4 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. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.