Senior Specialist, QA (Mfg Support)

Lonza; Singapore; On-site; SGD 70,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Family coverage option

Company transport from MRT to Tuas

Professional growth opportunities

Job summary

Lonza Group in Singapore is seeking a QA Specialist/Senior Specialist to support daily QA activities for a multi-product cGxP contract manufacturing facility. This site‑based role requires active collaboration on manufacturing floor, documentation review, and real-time quality guidance to uphold GMP standards.

You will review deviations, implement CAPA, and coordinate product release activities while ensuring compliance with SOPs and regulatory expectations.

Qualifications

• 1–3 years of QA experience in biopharma or GMP-regulated environment.
• Hands-on work with manufacturing activities and cross-functional teams.
• Strong understanding of GMP, quality systems and regulatory expectations.

Responsibilities

• Coordinate lot disposition and product release activities, including shipping documentation.
• Review and approve SOPs, protocols, reports, batch records, and other quality-related documents.
• Provide Quality oversight of product status and the quality tag-out system.
• Review deviation investigations, applying Root Cause Analysis to support timely closure.
• Oversee CAPA implementation and ensure timely and effective closure.
• Provide real-time Quality guidance on manufacturing floor activities in accordance with GMP, SOPs, and policies.
• Support manufacturing changeovers and day-to-day QA activities within a GMP biopharmaceutical facility.
• Identify cGMP/GDP non-compliance and provide appropriate corrective guidance.
• Analyze data, resolve quality issues, and recommend process improvements.
• Participate in manufacturing walkdowns, Regulatory and Customer Audits, and related follow-up activities.
• Lead and coordinate Quality projects and continuous improvement initiatives.
• Provide compliance guidance and Quality support to cross-functional teams.

Skills

QA operations

GMP knowledge

Cross-functional collaboration

Root Cause Analysis

Education

Bachelor's degree in a relevant discipline

Tools

Documentation systems

Job description

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

This is a fully site‑based shift role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety 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.
• Coordinate lot disposition and product release activities, including shipping documentation.
• Review and approve SOPs, protocols, reports, batch records, and other quality‑related documents
• Provide Quality oversight of product status and the quality tag‑out system.
• Review and approve deviation investigations, applying Root Cause Analysis to support timely closure.
• Oversee CAPA implementation and ensure timely and effective closure.
• Provide real‑time Quality guidance on manufacturing floor activities in accordance with GMP, SOPs, and policies.
• Support manufacturing changeovers and day‑to‑day QA activities within a GMP biopharmaceutical facility.
• Identify cGMP/GDP non‑compliance and provide appropriate corrective guidance.
• Analyze data, resolve quality issues, and recommend process improvements.
• Participate in manufacturing walkdowns, Regulatory and Customer Audits, and related follow‑up activities.
• Lead and coordinate Quality projects and continuous improvement initiatives.
• Provide compliance guidance and Quality support to cross‑functional teams.
• Build strong relationships with internal and external stakeholders.
• Perform other duties as assigned by the supervisor.

What we’re looking for

• Degree from a recognized institution in a relevant discipline.
• 1–3 years of relevant experience in a similar role, preferably within a biopharmaceutical or GMP‑regulated environment.
• Relevant QA Operations experience in a biopharmaceutical manufacturing environment.
• Hands‑on experience working and collaborating with cross‑functional teams on manufacturing activities.
• Good understanding of Quality Management Systems and GMP requirements.
• Meticulous, systematic, and detail‑oriented.
• Strong team player with a focus on safety, quality, compliance, 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.

Reference: R80071

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast‑moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.