Lot Review QA Specialist II (Operations)

Lonza; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global leader in life sciences in Singapore is seeking a Lot Review QA Specialist II. This role involves day-to-day Quality Assurance support in a GMP Biotech Manufacturing facility. Candidates should have relevant degrees and experience in compliance with regulatory standards. Join a dynamic workplace that values diversity, professional growth, and comprehensive benefits.

Benefits

Competitive compensation

Professional growth opportunities

Comprehensive medical insurance

Company transport from MRT locations

Diversity and inclusion initiatives

Qualifications

• 3 to 5 years of experience in a similar industry or role.
• Familiarity with FDA, EMEA, and ICHQ7 standards.
• Experience in a GMP facility quality management system.

Responsibilities

• Support day-to-day QA activities per SOPs/policies.
• Review and approve SOPs, protocols, reports, and records.
• Lead small projects and manage deliverables effectively.

Skills

Quality Assurance

Regulatory requirements knowledge

Attention to detail

Team player

Education

Degree from recognized institution

Diploma

Job description

Lot Review QA Specialist II (Operations)

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

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.

Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

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

• Support day-to-day QA activities in compliance with SOPs/policies in a multi-product, GxP contract manufacturing facility.
• Ensure process awareness, identifying operational factors affecting the process.
• Review and approve SOPs, protocols, reports, and records.
• Troubleshoot issues, weighing all information to determine optimal solutions.
• Lead small projects and manage deliverables effectively.
• Build strong working relationships with internal and external customers.
• Plan and coordinate future activities with other departments.
• Develop into a qualified trainer in the area of expertise.
• Review batch records, raise deviations, and compile lot genealogy.
• Escalate process events based on SOPs/policies.
• Support changeover activities and provide oversight for document changes.
• Detect non-compliance with cGMP/GDP, provide corrective guidance.
• Participate in walkdowns, audits, and provide feedback for improvement.
• Lead or participate in deviation investigations, change controls, and CAPA plans.

What we’re looking for

• Degree from recognized institution with 3 to 5 years’ experience in a similar type of industry or a similar job role.
• Diploma with 5 – 7 years’ experience 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.
• Meticulous and Systematic, team player, with strong focus on safety, quality and timelines.
• Able to operate independently with minimum supervision.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.