Quality Assurance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Auckland, New Zealand

About the Role:

Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide essential quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams.

You'll help maintain GMP compliance, investigate quality events, and drive continuous improvement initiatives while working in a collaborative environment focused on delivering life-changing products to our customers.

What You'll Do:

• Facilitate quality system documentation (SOP's, Standard Forms, BMRs, etc), including writing, reviewing and issuing documents.
• Review batch manufacturing records and documentation and release product for supply, and chemicals and components for manufacture.
• Review, process and approve problem records including deviations, non-conforming product, corrective and preventative actions in Trackwise and any other Thermo Fisher approved software.
• A proactive approach to Quality is required and the Quality Management System is to be maintained accordingly.
• Lead and complete internal audits according to the annual auditing program.
• Train others in quality systems and documentation, articulate and advance Quality Assurance principles positively and proactively at shop floor level.
• Champion and participate wholeheartedly in process improvement teams and complete any assigned actions.
• Take part in the change management activities across Australia and New Zealand sites, as and when required.
• Complete other activities that support maintaining and operating the Quality System.
• Observe all safety rules which are established to maintain safe work practices, including wearing personal protective equipment (PPE}. Conduct proactive hazard identification and report any accidents, incidents and near misses.

Education

• Bachelor's Degree required, no prior experience required, preferably in a GMP manufacturing environment
• Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
• Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous

Experience

• Experience working in a biological manufacturing environment advantageous
• Thorough knowledge of FDA, EMA, ISO, and international GMP regulations
• Proven ability to review and approve GMP documentation, batch records, and quality records

Benefits

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.

• Flexibility: Balance your work and personal life with flexible arrangements.

• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.

• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.

• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.