GMP Quality Assurance Specialist

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

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.