QA Specialist

i9 Sports - Mountain View, CA; Southwest; On-site; SGD 48,000 - 72,000; Full time

Job summary

An established industry player in life sciences is seeking a QA Specialist to oversee manufacturing in a cutting-edge GMP biotech facility. This role offers the opportunity to engage with innovative technologies and contribute to the production of life-saving therapies. You will be responsible for ensuring compliance with quality standards and regulatory requirements while supporting day-to-day QA activities. If you are meticulous, systematic, and a team player with a passion for quality and safety, this position will allow you to make a significant impact on improving lives through science. Join a company that values creativity and problem-solving in a collaborative environment.

Qualifications

• 3-5 years of experience in a similar industry or role.
• Familiarity with regulatory requirements like FDA and EMEA.

Responsibilities

• Support QA activities in compliance with SOPs in a GxP facility.
• Lead small projects and manage deliverables effectively.
• Participate in audits and provide feedback for improvement.

Skills

Quality Management System

Regulatory Compliance

Problem Solving

Team Collaboration

Attention to Detail

Education

Degree from recognized institution

Diploma

Job description

Today, Lonza is a global leader in life sciences operating across three 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 to help people.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a QA Specialist you will be responsible for providing oversight into manufacturing in a large-scale, multi-product, GMP biotech contract manufacturing facility.

Key responsibilities:

• 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.

Key Requirements:

• 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.

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.