Specialist 2, QA (Validation and Technical Compliance)

As a QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGMP contract manufacturing facility.

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 QA oversight for QC/DS lab services, including review and approval of protocols, reports, deviations, discrepancies, and CAPA implementation.

• Apply Root Cause Analysis tools to ensure effective and timely closure of quality records.

• Oversee Quality Change Requests related to lab service changes.

• Collaborate with cross-functional teams, ensuring timely communication and updates.

• Build strong working relationships with internal and external stakeholders.

• Participate in cross-functional walkdowns and provide QA feedback.

• Lead and coordinate projects, ensuring deliverables are met.

• Develop capabilities as a Qualified Trainer and support audits as an SME for QA oversight.

What we’re looking for

• Bachelor's degree with significant years’ experience in Quality Assurance in the Biopharmaceutical industry.

• Familiarity with Regulatory requirements and local Codes & Standards (eg. FDA, EMA and ICH Quality Guidelines)

• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

• Able to operate independently with minimum supervision for routine work within established policies and procedures and receives detailed instructions on new projects and assignments.

• Meticulous and Systematic.

• Team player, with strong focus on safety, quality and 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.