Quality Assurance Associate, Sterile Manufacturing

Baxter International Inc.; Sydney; On-site; AUD 70,000 - 100,000; Full time

Job summary

Baxter International Inc. is seeking a motivated Quality Assurance Associate to join the Quality team at the Toongabbie manufacturing facility.

You will support the site's Quality Management System, ensuring batch documentation meets cGMP requirements and driving continuous improvement initiatives. Responsibilities include reviewing batch documents, investigating complaints, performing trend analysis, and supporting CAPA-driven improvements.

Qualifications

• Tertiary degree in Pharmacy, Science, Engineering or related fields.
• Experience in Sterile Manufacturing and/or Quality Assurance processes.
• Strong understanding of regulatory requirements and quality standards.
• Outstanding attention to detail and analytical skills.
• Excellent communication and teamwork abilities.
• Proficiency in quality management software and tools.
• Ability to strictly adhere to deadlines and manage multiple tasks.

Responsibilities

• Ensure each batch document is thoroughly reviewed for compliance prior to releasing batch to the market.
• Ensure each complaint is properly reviewed and investigated, and closed in timely manner following with Global Quality Policy and applicable Regulatory requirements.
• Perform trend analysis of complaints and waste/scraps and work with Manufacturing team to implement continuous improvement/complaint & waste/scrap reduction.
• Ensure proper root cause analysis is performed when a trend of Customer Complaint is received or a deviation is reported in MPI database.
• Ensure proper root cause analysis in Non-Conformance Reports (NCRs) and Manufacturing Process Improvements (MPIs) to continuously improve Right First Time performance.
• Manage Manufacturing Non-Conformance Reports (NCRs) and Manufacturing Process Improvements (MPIs) to ensure they are adequately written, closed in timely manner and all associated CAPAs are implemented.
• Provide inputs for Monthly Indicators, Management Review, and Annual Product Review.
• Support Release Department as needed.

Skills

Quality Assurance

Sterile Manufacturing

Regulatory knowledge

Attention to detail

Analytical skills

Communication

Teamwork

Education

Pharmacy degree

Science/Engineering degree

Tools

Quality management software

Job description

Baxter International Inc. is seeking a motivated Quality Assurance Associate to join the Quality team at the Toongabbie manufacturing facility.

You will support the site's Quality Management System, ensuring batch documentation meets cGMP requirements and driving continuous improvement initiatives. Responsibilities include reviewing batch documents, investigating complaints, performing trend analysis, and supporting CAPA-driven improvements.