Quality Assurance Officer

Thermofisher Scientific; Auckland; On-site; NZD 70,000 - 100,000; Full time

Job summary

Thermo Fisher Scientific seeks a QA professional to join our GMP quality assurance team in Auckland. You will ensure product quality and regulatory compliance while driving continuous improvement initiatives across cross-functional teams.

The role emphasizes detailed documentation reviews, audits, and adherence to cGMP and ISO standards within controlled environments, with standard Monday–Friday office-based scheduling.

Qualifications

• Bachelor's degree required in science, engineering or related field
• Experience with quality systems and documentation (batch records, SOPs, deviations) preferred
• Knowledge of cGMP, ISO standards and regulatory requirements advantageous
• Experience with internal audits and supplier quality improvement helpful
• Strong written and verbal communication skills

Responsibilities

• Ensure quality standards are consistently applied in GMP environment
• Support continuous improvement initiatives and root cause analysis
• Collaborate with cross-functional teams to maintain regulatory compliance

Skills

Quality assurance

GxP knowledge

Analytical thinking

Documentation review

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

TrackWise

SAP

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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.

DESCRIPTION:

At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

REQUIREMENTS:

• Bachelor's Degree required. Experience in pharmaceutical, medical device or regulated industry preferred
• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
• Additional certifications in Quality Systems or GMP desirable but not essential
• Knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements
• Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
• Proficiency in quality management software systems (TrackWise, SAP, etc.) advantageous
• Demonstrated ability to perform detailed documentation review and quality assessments
• Strong analytical and problem-solving skills for quality investigations and root cause analysis
• Excellent written and verbal communication skills
• Ability to work independently and collaborate effectively with cross-functional teams
• Experience conducting internal quality audits and supporting external regulatory audits
• Proficient computer skills including Microsoft Office applications
• Strong attention to detail and commitment to accuracy
• Ability to prioritize and adapt in a changing environment
• Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
• Must be able to work in controlled environments wearing required PPE

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.