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.
