Quality Coordinator

Our Client
Baxter Laboratories is a TGA licensed manufacturer that offers complete supply services for skin care, sunscreen and topical pharmaceutical products, including Research and Development, Regulatory Services, Manufacturing, Filling, Warehousing and Global Distribution. Working with best in class and popular brands that are in all major Australian retailers.
The Baxter Laboratories site based in Boronia has experienced year on year growth with expectations for further double figure growth in the future.

Role
Reporting to the Quality Manager, the Quality Control Stability Coordinator will take ownership of the stability program across the site. You'll manage everything from protocol design through to chamber qualification, testing schedules, and trend analysis — making sure the program stands up to TGA, PIC/S GMP and ICH scrutiny at every step.
This is a hands-on, technical role for someone who genuinely enjoys the detail work of stability science. You'll be the go-to person when questions come in from sponsors, auditors, or other departments, and you'll play a key part in how Baxter manages risk around process, packaging and raw material changes.

Key responsibilities include:

• Design and implement risk-based SOPs and workflows for accelerated, initial and ongoing stability programs
• Author, review and approve stability protocols, covering parameters, storage conditions, test intervals, container-closure systems and target market requirements
• Oversee mapping, qualification, calibration and ongoing environmental monitoring of stability chambers
• Manage samples to ensure stability batches start on time and are tested at the right intervals
• Review analytical stability data and evaluate trends against specification
• Lead or support OOS/OOT investigations, deviations, root cause analysis and CAPAs
• Assess process, packaging, raw material or site changes for their impact on product stability
• Act as SME during TGA audits and regulatory inspections, and for sponsor queries on the stability program
• Work with the business to define stability responsibilities between Baxter and the Sponsor

Skills Required
Baxter Laboratories is an organisation filled with talented and energetic people who are incredibly passionate about the brands they work with and the people within their organisation. Beyond just the below skills, we desire candidates who are excited about the journey of growth that they are on!

• At least 5 years' hands-on experience managing stability programs within pharmaceutical, therapeutic or another tightly regulated contract manufacturing environment
• In-depth, practical knowledge of TGA regulations, PIC/S GMP (Part 1, Chapter 6) and ICH Quality Guidelines (Q1A-Q1F)
• Experience running OOS/OOT investigations and managing chamber qualifications
• Strong computer literacy across the Microsoft Office suite
• Excellent communication skills and comfortable in a fast-paced, dynamic environment
• High accountability, strong time management and real attention to detail
• Strong work ethic and a good level of initiative

Get in Touch
If you require more information on the role or if you have any further questions, please contact Luke Batten via email on [email protected]