Quality Assurance Associate

Baxter; Sydney; On-site; AUD 70,000 - 90,000; Full time

Job summary

Baxter is seeking a motivated Quality Assurance Associate to join the Quality team at the Toongabbie manufacturing facility. The role focuses on ensuring batch documentation compliance, complaint investigations, and driving continuous improvement within a sterile manufacturing environment.

The successful candidate will possess a tertiary degree in a related field, strong regulatory knowledge, and excellent attention to detail.

Qualifications

• A tertiary degree in Pharmacy, Science, Engineering or related fields is required.
• Experience with sterile manufacturing and/or quality assurance processes is preferred.
• Strong understanding of regulatory requirements and quality standards is essential.

Responsibilities

• Review batch documents for compliance before market release.
• Review and investigate complaints, close investigations per Global Quality Policy and regulatory requirements.
• Perform trend analysis of complaints and waste, drive continuous improvement with Manufacturing.
• Ensure root-cause analysis for trends in customer complaints or deviations in MPI/NCRs.
• Manage NCRs and MPIs; ensure timely writing, 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 thinking

Strong communication

Team collaboration

Deadline management

Education

Tertiary degree in Pharmacy, Science, Engineering

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.

The Role

We are seeking a motivated and detail-oriented Quality Assurance Associate to join our Quality team at our Toongabbie manufacturing facility.

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 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process.