Quality Assurance Specialist

Role overview

Join a collaborative quality team in Auckland, New Zealand, where you will support manufacturing operations by ensuring strong quality compliance and GMP discipline. In this role, you will review documentation, monitor processes, work with cross-functional partners, and help sustain a quality system that supports safe, effective products for customers worldwide.

The position is focused on maintaining compliance, investigating quality issues, and contributing to continuous improvement in a regulated manufacturing environment.

Work schedule and environment

This is a standard Monday to Friday role. The work setting requires adherence to GMP safety standards and office-based activities, with a strong expectation of safe working practices at all times.

Key responsibilities

• Prepare, update, review, and issue quality system documents such as SOPs, standard forms, and batch manufacturing records.
• Examine batch records and supporting documentation, then authorize product release for supply as well as chemicals and components for manufacturing.
• Evaluate, process, and approve quality events, including deviations, non-conforming product, and corrective and preventive actions in Trackwise and other approved systems.
• Help maintain an effective Quality Management System through a proactive quality mindset.
• Carry out internal audits in line with the annual audit plan.
• Train colleagues on quality systems and documentation, and promote quality assurance principles on the shop floor.
• Contribute actively to process improvement initiatives and complete assigned follow-up actions.
• Support change management activities across Australia and New Zealand sites when required.
• Perform additional tasks needed to operate and maintain the quality system.
• Follow all safety procedures, use PPE appropriately, identify hazards proactively, and report accidents, incidents, and near misses.

Requirements

• A bachelor's degree is required, and no previous experience is necessary.
• A background in GMP manufacturing is preferred.
• Relevant study in Chemistry, Biology, Engineering, Life Sciences, or a related scientific field is preferred.
• Additional credentials such as ISO auditor or Six Sigma certification are considered an advantage.
• Experience in a biological manufacturing environment is beneficial.
• Strong knowledge of FDA, EMA, ISO, and international GMP requirements is expected.
• Ability to review and approve GMP documents, batch records, and quality records is essential.

Benefits

• Comprehensive health and wellbeing support, including wellness programs and confidential employee assistance.
• Flexible working arrangements to help balance professional and personal commitments.
• Generous leave options, including the ability to purchase extra leave, paid birthday leave, and company-paid parental leave.
• Paid volunteer time to support charitable and community causes.
• Access to learning and development resources such as online courses, workshops, and mentorship opportunities.

Additional information

The employer’s mission is to help make the world healthier, cleaner, and safer by supporting customers with solutions for major scientific and environmental challenges. The organization values integrity, intensity, innovation, and involvement, and welcomes diverse backgrounds, experiences, and perspectives. It is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other legally protected status.

No application deadline, salary figure, vacancy count, or start date was specified.