Quality Operations Specialist I (12-hour Rotating Shift)

Job Description :

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Location/Division Specific Information

This position is based at our 31 Joo Koon Circle facility in Singapore, part of Thermo Fisher's Pharma Services Group. The site is equipped with innovative technology and supports high-quality pharmaceutical manufacturing and packaging operations. You will be part of a team that encourages collaboration and prioritizes ongoing learning while providing robust training opportunities for professional growth.

This role will initially follow normal working hours (8:00 AM - 5:15 PM) for training, with occasional support for night testing. Once ready, the role will transition to a rotating day/night 24x5 shift pattern, depending on operational needs.

Discover Impactful Work:

Make a difference while advancing your career in a global science leader.

At Thermo Fisher Scientific, everything we do begins with our mission-to enable our customers to make the world healthier, cleaner, and safer. As a Quality Operations Specialist, you will play a key role in maintaining the integrity of our products and supporting world-class manufacturing processes that impact lives every day.

A day in the Life:

• Follow site safety requirements and maintain safe working conditions during daily operations.
• Serve as a Quality representative on the manufacturing floor, resolving issues and ensuring compliance in real-time.
• Draft and review quality operational procedures and support cross-functional SOP development.
• Coordinate compliance activities on the shop floor and proactively identify and address quality concerns.
• 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.
• To support shift work when required.

Keys to Success:

Education

• Bachelor's degree in Life Sciences, Chemical Engineering, Biochemical Engineering, or a related scientific field of study.

Experience

• 1 to 3 years of experience in pharmaceutical or biopharmaceutical quality operations is preferred.
• Fresh graduates with strong academic backgrounds in relevant fields are welcome to apply.
• Exposure to Quality Management Systems and biologics manufacturing will be an added advantage.

Knowledge, Skills, Abilities

• Solid understanding of cGMP and regulatory compliance standards.
• Strong attention to detail and effective communication skills.
• Ability to coordinate multi-functional teams and drive collaboration.
• Analytical perspective with a proactive approach to solving quality issues.
• Familiarity with quality risk management tools is beneficial.

Physical Requirements / Work Environment

• May require walking, standing, and lifting small objects or tools for short durations.
• Operation of computers and other equipment is required for brief periods.
• Work is performed in a cleanroom environment cleanroom attire (e.g., gown, gloves, mask) is required at all times.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!