Stability Coordinator

Lipa Pharmaceuticals Limited; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Immediate start with onsite carparking

Results-driven team

Ongoing training and support

Supportive management with clearVision

Rewards and Recognition program

Job summary

Lipa Pharmaceuticals Limited is seeking a Stability Coordinator to manage the end-to-end stability program in compliance with TGA and GMP. The role collaborates with QA, Regulatory Affairs and Production to ensure product integrity across lifecycles.

The successful candidate will schedule stability samples, perform HPLC/GC/FTIR/UV-Vis testing, maintain documentation, and review data to identify trends and excursions. Onsite parking and career development are offered.

Qualifications

• Experience in a Quality Control or Stability laboratory within the pharmaceutical or complementary medicine industry.
• Strong understanding of GMP, TGA and ICH stability guidelines.
• Hands-on experience with analytical instrumentation (HPLC, GC, FTIR, UV-Vis, etc.).
• Strong data analysis and trending skills.
• High attention to detail and strong documentation skills.

Responsibilities

• Coordinate and maintain the site stability program in accordance with TGA, GMP and ICH guidelines.
• Schedule and manage stability samples for ongoing and new products.
• Ensure correct storage and monitoring of stability samples under controlled environmental conditions.
• Monitor, record and review temperature and humidity data for stability chambers and elevate any excursions.
• Perform physical and chemical testing of stability samples in accordance with approved specifications.
• Conduct analytical testing using techniques such as HPLC, GC, FTIR, UV-Vis and other relevant methods.
• Prepare and standardise reagents and solutions required for laboratory testing.
• Review and compare analytical results against approved specifications and stability protocols.
• Trend and analyse stability data to identify potential quality issues.
• Accurately document all testing activities in compliance with GMP and TGA requirements.
• Maintain stability protocols, reports and summary documentation for regulatory purposes.
• Support investigations relating to out-of-specification (OOS), out-of-trend (OOT) results and deviations.
• Assist with preparation of stability reports for regulatory submissions and product registrations.

Tools

HPLC

GC

FTIR

UV-Vis

Job description

Lipa Pharmaceuticals is Australia’s leading manufacturer of complementary medicines, specialising in vitamins, pharmaceuticals, and health food supplements. We have the capacity to produce a wide range of products including tablets, hard and soft capsules, liquids, powders, creams, gels, and probiotics.

We are proud to have been recognised by Complementary Medicines Australia as the ‘High-Quality Manufacturer of the Year’ on nine occasions for the exceptional products we create.

The Opportunity

We currently have a fantastic opportunity available for a Stability Coordinator on a full time permanent basis. The Stability Coordinator is responsible for the end to end management of Lipa Pharmaceuticals stability program ensuring stability testing of finished products is in compliance with TGA requirements.

This role plays a critical part in monitoring product quality throughout its shelf life by conducting analytical testing, maintaining stability programs and ensuring accurate documentation and reporting. The Stability Coordinator works closely with Quality Control, Quality Assurance, Regulatory Affairs and Production teams to ensure products remain safe, effective and compliant throughout their lifecycle.

What we offer

• Immediate start with onsite car parking
• Work with a results-driven and passionate team
• Ongoing training and support
• Guidance by a supportive management team with a clear vision
• Employee benefits, including a Rewards and Recognition Program

Responsibilities

• Coordinate and maintain the site stability program in accordance with TGA, GMP and ICH guidelines.
• Schedule and manage stability samples for ongoing and new products.
• Ensure correct storage and monitoring of stability samples under controlled environmental conditions.
• Monitor, record and review temperature and humidity data for stability chambers and elevate any excursions.
• Perform physical and chemical testing of stability samples in accordance with approved specifications.
• Conduct analytical testing using techniques such as HPLC, GC, FTIR, UV-Vis and other relevant methods.
• Prepare and standardise reagents and solutions required for laboratory testing.
• Review and compare analytical results against approved specifications and stability protocols.
• Trend and analyse stability data to identify potential quality issues.
• Accurately document all testing activities in compliance with GMP and TGA requirements.
• Maintain stability protocols, reports and summary documentation for regulatory purposes.
• Support investigations relating to out-of-specification (OOS), out-of-trend (OOT) results and deviations.
• Assist with preparation of stability reports for regulatory submissions and product registrations.
• Experience in a Quality Control or Stability laboratory within the pharmaceutical or complementary medicine industry
• Strong understanding of GMP, TGA and ICH stability guidelines
• Hands-on experience with analytical instrumentation (HPLC, GC, FTIR, UV-Vis, etc.)
• Strong data analysis and trending skills
• High attention to detail and strong documentation skills
• Ability to manage timelines and coordinate multiple stability schedules
• Strong communication and teamwork skills

Please Note

Lipa Pharmaceuticals has a strong commitment to health and safety, with a pre-employment medical requiring successful completion, prior to an offer being made. We do not accept unsolicited applications from third parties. Applicants must be eligible to work in Australia. Additionally, as our facility is not accessible by public transport you will need your own transportation to get to work.

Lipa Pharmaceuticals is an Equal Employment Opportunity (EEO) employer. We are committed to providing a diverse and inclusive work environment for all employees and applicants, regardless of race, colour, nationality, gender, age, disability, religion, sexual orientation, gender identity, or any other characteristic protected by law. We encourage individuals from all backgrounds to apply