Real-Time GMP Quality Assurance Specialist

Thermofisher; Brisbane; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Health & Wellbeing benefits

Flexible work arrangements

Paid parental leave

Job summary

Thermo Fisher Scientific Australia is seeking a Quality Assurance professional to support real-time quality assurance in a GMP environment at the Banyo site. The role focuses on batch record reviews, logbook audits, and approvals of QA documentation as part of our Quality-on-the-floor program.

Ideal candidates will have 3+ years in a GMP setting, strong communication skills, and a tertiary degree in biotechnology, biochemistry, or related field.

Qualifications

• Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations.
• Strong written, verbal and presentation skills.
• Experience in QA in GMP-regulated environment preferred.

Responsibilities

• Perform real-time batch record reviews and ensure product quality during manufacturing and postproduction.
• Conduct routine audits of logbooks for completeness and cGMP compliance.
• Perform final QA review and approval of batch-related documentation.
• Actively participate in deviation investigations and risk assessments.
• Approve QA documents and control records within the Quality Management System.

Skills

GMP knowledge

Quality Assurance

Communication skills

Documentation skills

Education

Biotechnology/related degree

Job description

Thermo Fisher Scientific Australia is seeking a Quality Assurance professional to support real-time quality assurance in a GMP environment at the Banyo site. The role focuses on batch record reviews, logbook audits, and approvals of QA documentation as part of our Quality-on-the-floor program.

Ideal candidates will have 3+ years in a GMP setting, strong communication skills, and a tertiary degree in biotechnology, biochemistry, or related field.