Quality Assurance Associate - Sterile Manufacturing & Compliance

Baxter Global; Sydney; On-site; AUD 70,000 - 95,000; Full time

Job summary

Baxter is seeking a motivated Quality Assurance Associate to join the Quality team at our Toongabbie manufacturing facility in NSW. You will support the Quality Management System by ensuring batch documentation complies with cGMP requirements and contribute to continuous improvement initiatives that enhance product quality and compliance.

Key responsibilities include reviewing batch documents, investigating customer complaints, performing trend analyses, and driving CAPA implementations.

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 simultaneously.

Responsibilities

• Review batch documentation for compliance prior to release.
• Investigate and close customer complaints in line with Global Quality Policy and regulatory requirements.
• Conduct trend analysis of complaints and waste, drive continuous improvement with Manufacturing.
• Perform root cause analysis for trends in customer complaints or deviations in MPI databases.
• Manage NCRs and MPIs to ensure timely closure and CAPA implementation.
• Provide inputs for Monthly Indicators, Management Review, and Annual Product Review.
• Support Release Department as needed.

Skills

Attention to detail

Analytical skills

Communication skills

Teamwork

Education

Tertiary degree in Pharmacy, Science, Engineering or related fields

Tools

Quality management software

Job description

Baxter is seeking a motivated Quality Assurance Associate to join the Quality team at our Toongabbie manufacturing facility in NSW. You will support the Quality Management System by ensuring batch documentation complies with cGMP requirements and contribute to continuous improvement initiatives that enhance product quality and compliance.

Key responsibilities include reviewing batch documents, investigating customer complaints, performing trend analyses, and driving CAPA implementations.