Specialist, QA Operations (Master Batch Record)

As a QA specialist you will provide day to day Quality Assurance activities support in accordance with approved SOPs/Policies for a large scale GMP Biotech 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

• Review batch records/logbooks; escalate deviations promptly

• Compile lot genealogy and prepare disposition packages for product release

• Oversee product status and shipping documentation

• Manage quality tag-out system

• Review/approve deviation investigations using RCA; ensure timely closure

• Monitor CAPA implementation and closure

• Escalate shop floor process events per SOPs

• Support changeovers and ensure compliance

• Provide QA oversight for MBRs, SOPs, forms, and logbooks

• Review quality-related change requests

• Identify cGMP gaps and drive corrective actions

• Conduct shop floor QA walk-downs and provide feedback

• Support regulatory inspections and customer audits

• Lead/coordinate team projects and stakeholder engagement

• Act as Change Agent/Reviewer/Approver for quality documents

• Support deviation and change control management

What we’re looking for

• Degree with 2-5 years of experience in a in a similar type of industry or a similar job role.

• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).

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

• Pleasant personality.

• Good oral and written communication skills.

• 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.