Quality Assurance Associate

Zvh; Sydney; On-site; AUD 70,000 - 100,000; Full time

Job summary

Baxter in Australia is seeking a motivated Quality Assurance Associate for our Toongabbie manufacturing site. You will help maintain the site's Quality Management System by ensuring batch documentation meets cGMP requirements, coordinating investigations of customer complaints, and supporting continuous improvement initiatives that enhance product quality and compliance.

Ideal candidates have a tertiary science or engineering degree and proven experience in sterile manufacturing or QA, with

Qualifications

• Bachelor's degree in Pharmacy, Science, Engineering or related field required.
• Experience in sterile manufacturing and/or QA processes preferred.
• Strong understanding of regulatory requirements and quality standards.
• Excellent attention to detail and analytical skills.

Responsibilities

• Review batch documentation for compliance prior to release to market.
• Investigate customer complaints and ensure timely closure per policy.
• Perform trend analysis of complaints and waste; drive improvements.
• Conduct root cause analyses for trends and deviations in MPI/NCRs.
• Ensure CAPAs are implemented and tracked in manufacturing processes.
• Support Monthly Indicators, Management Review, and Annual Product Review.
• Assist Release Department as needed.

Skills

Quality Assurance

Sterile Manufacturing

Regulatory compliance

Attention to detail

Communication

Time management

Education

Bachelor's degree in Pharmacy, Science, Engineering or related field

Tools

Quality Management Software

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. #li-baxgen #LI-JB1 #ind-anz

The Role

We are seeking a motivated and detail-oriented Quality Assurance Associate to join our Quality team at our Toongabbie manufacturing facility. In this role, you will support the site's Quality Management System by ensuring batch documentation complies with cGMP requirements, coordinating customer complaint investigations, and contributing to continuous improvement initiatives that enhance product quality, reduce waste, and strengthen compliance. This is an excellent opportunity for a quality professional looking to build their career within a highly regulated manufacturing environment.

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.

Key Requirements

• A Tertiary degree in Pharmacy, Science, Engineering or related fields
• Proven 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
• Outstanding communication and collaboration skills.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.