The QA Specialist provides Quality Assurance oversight for manufacturing activities within a large-scale, multi-product GMP biopharmaceutical contract manufacturing facility, ensuring compliance with regulatory and internal quality standards.
The QA Senior Specialist will be required to perform shift.
What you’ll get
An agile career and dynamic working culture in a global life sciences leader.
An inclusive and ethical workplace that values diversity and integrity.
Competitive compensation programs that recognize high performance.
Professional growth opportunities through cross-functional projects and global exposure.
Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.
Company transport provided from designated MRT locations to and from the Tuas site.
Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits
What you’ll do:
Provide daily QA support in line with established SOPs, policies, and GxP standards.
Review and approve SOPs, protocols, reports, batch records, and other quality-related documents.
Evaluate batch records and logbooks, assist with changeovers, and compile lot genealogy to support batch disposition activities.
Participate in or lead deviation investigations, change controls, CAPA processes, and closure of discrepancy reports.
Identify and resolve quality and operational issues, recommending effective corrective actions.
Manage small-scale projects and ensure timely delivery of assigned tasks.
Foster strong relationships with both internal teams and external partners.
Assist in regulatory inspections and customer audits.
Build competencies as an internal GxP auditor and Qualified Trainer.
Carry out additional responsibilities as required.
What we’re looking for:
Bachelor’s degree with relevant experience in Quality Assurance within the biopharmaceutical sector.
Proven experience in QA operations in a GMP-regulated biopharma environment.
Practical experience collaborating with cross-functional manufacturing teams.
Solid understanding of quality management systems and GMP compliance requirements.
Familiarity with regulatory guidelines such as FDA, EMA, and ICH.
Strong analytical, problem-solving, communication, and organizational abilities.
Detail-oriented, structured, and a strong team player with a focus on safety, quality, and meeting timelines.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Skills Required
- Bachelor's degree with relevant experience in Quality Assurance within the biopharmaceutical sector.
- Proven experience in QA operations in a GMP-regulated biopharma environment.
- Practical experience collaborating with cross-functional manufacturing teams.
- Solid understanding of quality management systems and GMP compliance requirements.
- Familiarity with regulatory guidelines such as FDA, EMA, and ICH.
- Strong analytical, problem-solving, communication, and organizational abilities.
- Detail-oriented, structured, team player with focus on safety, quality, and meeting timelines.
- Willingness and ability to perform shift work on-site at the Tuas manufacturing site.
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
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