Quality Operation Specialist

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

J ob responsibilities

• Follow site safety requirements and maintain a safe working condition during daily operations.
• Provide shop floor QA oversight and problem-solving support to manufacturing operations, ensuring routine compliance.
• Perform Quality Monitoring for aseptic manufacturing processes and Acceptable Quality Checks for sterile products.
• 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.
• Participate in site operational readiness programs 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.