Sterile QA Associate: Quality, Compliance & Impact

Baxter Healthcare; Sydney; On-site; AUD 65,000 - 90,000; Full time

Job summary

Baxter Healthcare Australia is seeking a motivated Quality Assurance Associate for the Toongabbie manufacturing site. You will support the site's Quality Management System, ensuring batch documentation meets cGMP requirements and contribute to continuous improvement initiatives.

This role provides a pathway to grow within a highly regulated manufacturing environment, collaborating with cross-functional teams to strengthen product quality and compliance.

Qualifications

• 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.

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

Sterile Manufacturing

Quality Assurance processes

Regulatory requirements and quality

Attention to detail

Communication and teamwork

Quality management software/tools

Deadlines and multitasking

Education

Tertiary degree in Pharmacy/Science/Engineering

Job description

Baxter Healthcare Australia is seeking a motivated Quality Assurance Associate for the Toongabbie manufacturing site. You will support the site's Quality Management System, ensuring batch documentation meets cGMP requirements and contribute to continuous improvement initiatives.

This role provides a pathway to grow within a highly regulated manufacturing environment, collaborating with cross-functional teams to strengthen product quality and compliance.