QA Specialist I

Work Schedule12 hr shift/daysEnvironmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsPosition SummaryJoin Thermo Fisher Scientific Inc. as a Quality Ops Specialist for impactful work.ResponsibilitiesFollow 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/QualificationsEducation: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.