Analyst QC, BioChemistry

3 days ago

Tuas, Singapore Lonza Full time $60,000 - $100,000 per year

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Singapore, Tuas Singapore

Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. We offer our people the opportunity to own their careers and make a genuine impact on the world.

We are the 1st biologics contract manufacturer in Singapore, providing exposure to biotech and pharmaceutical companies and manufacturing technologies for future treatments and cell therapies. Our global network is recognized for high-quality services, regulatory compliance, and innovative technology.

The QC Analyst will support the Biochemistry Area in the QC Lab to assist with Lot Release activities.

Responsibilities
  1. Perform testing and analysis efficiently to support business needs.
  2. Analyze final products, in-process, and stability samples following SOPs and Test Methods.
  3. Document and review results in compliance with cGMP standards.
  4. Execute methods including ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, and other physiochemical techniques.
  5. Support general lab operations such as housekeeping, equipment maintenance, and supplies management.
  6. Prepare and maintain standards and reagents as per GMP documentation.
  7. Ensure data integrity is maintained.
  8. Contribute to operational improvements and continuous enhancement initiatives.
  9. Troubleshoot analytical methods and equipment issues.
  10. Participate in equipment qualification, maintenance, and troubleshooting.
  11. Support OOS and deviation investigations, drafting reports.
  12. Train staff on test methods and support method transfers and validation.
  13. Author and review Change Controls, Test Methods, and SOPs.
  14. Lead investigations into OOS and deviations.
Education / Experience
  1. Diploma or Degree with at least 3 years' experience in a Quality role within the biopharmaceutical industry.
  2. Relevant laboratory experience in biotech or medical fields preferred.
  3. Knowledge of regulatory requirements (FDA, EMEA, ICH).
  4. Understanding of GMP quality management systems.
  5. Willingness to embrace new challenges.
  6. Strong interpersonal and communication skills.
  7. Ability to prioritize and organize work effectively.
  8. Meticulous, systematic, and analytical mindset.
  9. Team-oriented with the ability to work independently, focusing on safety, quality, and timelines.

At Lonza, we value ethical achievements, respect our people and environment, and are committed to solving complex problems and developing innovative solutions to improve lives worldwide.

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