QA Operations Senior Specialist (12hours Rotating Shift)

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

Job Description

Position Summary

At Thermo Fisher Scientific Inc., we offer an outstanding opportunity for a Senior Quality Operation Specialist to join our dedicated team. In this meaningful role, you will be responsible for accomplishing quality operational and compliance activities to maintain GMP compliance across our shop floor, engineering, and warehouse. Under the vigilant mentorship of our QA Manager, you will ensure site adherence to GMP requirements and corporate policies, driving continuous improvements in our quality system. You’ll play a significant role in identifying near misses in the manufacturing area, safeguarding product quality, and ensuring patient safety.

Responsibilities

• Follow site safety requirements and maintain a safe working condition during daily operations.
• Provide shop floor QA supervision and problem-solving support to manufacturing operations, ensuring routine compliance.
• Perform Quality Monitoring for aseptic manufacturing processes and Acceptable Quality Checks for sterile products.
• Coordinate quality in microbiology, including vial reading for incubated media-filled vials.
• Support QC area by reviewing QC documents and participating in operational readiness programs.
• Assist QA manager with batch disposition and review validation documents, including computer system validation.
• Assess incoming materials for new product introductions and write operational procedures, reviewing all SOPs.
• Collect and analyze shop floor information, working with operations to resolve issues as a QA representative.
• Review and approve Master Batch Records and Master Formulation Records, ensuring compliance with TFS standards and cGMP requirements.
• Ensure all-time readiness for GMP and client audits, participating in deviation and OOS investigations.
• Lead root cause analysis with effective CAPA and support process validation, clean validation review, and approval.
• Establish and improve QA Operations procedures to enhance quality and efficiency continuously.
• Ensure all time readiness of the site for regulatory audit.
• Support the site Regulatory Inspections and client audit to assure that QA Operations related areas of each inspection are being accurately and efficiently handled.
• Involved in deviation and OOS investigation as quality representative:
• Participate in site operational readiness programmes like self-inspection, data integrity surveillance, fit and finish program.
• Review and approve Master Batch record and master formulation record in a timely manner to ensure MBR and MFR meet TFS quality standard and cGMP requirements.

EHS

• Implement emergency procedures and safe systems of work compliance.
• Adhere to environment, health, and safety rules, reporting and investigating all accidents, near misses, and rule breaches promptly.

Minimum Requirements/Qualifications

Education:

• Bachelor’s Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a Pharma-related Scientific Area.

Experience:

• 4-6 years of relevant Quality experience in Pharmaceuticals/Biopharmaceuticals is required.
• Experience in Quality Management Systems, quality operations, and biologics/aseptic training is an asset.