Stability Analyst

ABOUT THE COMPANY

UA Manufacturing is a new subsidiary located in Altona North Melbourne, invested by Uniasia Cosmetics Technology, a world-famous international cosmetics manufacturer. 

Specializing in the procurement, development, manufacturing, filling and packing of beauty and cosmetics products, we are passionate about cosmetics and beauty, and committed to offering superior and value-added services, such as product development, custom formulation and manufacturing solutions.

Our state-of-the-art facility has been built in strict accordance with TGA, GMP, ISO9001:2015, ISO 22716:2007 regulations and to meet the standard of a 100,000-purification factory. This ensures we have a superior clean production environment in our facility. In addition, we have sourced the world's leading automated production equipment which greatly enhances our production efficiency, saving on our client's time and costs.

As one of the largest cosmetic OEM in Australia we have a rapidly expanding customer base. At UA Manufacturing you can grow and develop as we do.

ABOUT THE POSITION

As the Stability Analyst for Cosmetics and Therapeutics, your primary responsibilities include overseeing the implementation and management of a robust stability program. This involves designing a comprehensive testing strategy, defining acceptance criteria, and ensuring compliance with industry standards and regulatory requirements. You will establish a systematic process for pulling representative samples at different production stages and conduct specialized Physical testing including HPLC analysis, to ensure product quality.

ROLES & RESPONSIBILITIES

Stability Program and Trending

• Define a comprehensive stability testing program for cosmetics products. This involves determining the testing parameters such as temperature, humidity, light exposure, and time intervals. Identify critical stability-indicating characteristics and set acceptance criteria.

Sample Collection and Storage

• Establish a systematic process for pulling representative samples from different batches of cosmetics products at various stages of production. Implement proper sample storage conditions to ensure stability and prevent degradation.

Stability Testing

• Execute stability testing according to the defined program. Common tests include visual inspection, pH measurement, viscosity testing, and microbial stability testing. 
• Use analytical techniques such as High-Performance Liquid Chromatography (HPLC) for quantitative analysis of active ingredients and potential degradation products.

Data Monitoring and Trending

• Implement a data management system to track and organize stability data over time. Monitor and analyze trends in stability data to identify any potential issues or deviations from expected results. 
• Set up a system for reporting and documenting stability trends, ensuring that any out-of-specification results are investigated and addressed. 
• Ensure that the stability program is designed and executed in compliance with relevant regulations and guidelines.

Documentation

• Maintain detailed documentation of the stability program, testing procedures, and results. Prepare stability reports for regulatory submissions or internal quality assessments. 

Pull Out Samples and Testing

• Sampling System

1. Develop a sampling plan that considers the critical points in the production process. 
2. Train personnel on proper sample collection techniques to ensure representative samples are obtained.

• Additional Testing Protocol

1. Define criteria for when additional testing is necessary, such as changes in raw materials, manufacturing processes, or unexpected stability results. 
2. Establish a protocol for conducting specialized testing, such as HPLC analysis, to assess specific aspects of product quality. 
3. Implement HPLC test methods for analyzing cosmetic products and Therapeutic. This may include testing for pH, Viscosity, density, and Other physical tests as required. 
4. Ensure that HPLC instruments are calibrated and maintained regularly for accurate and reliable results.

Quality and Compliance Assurance

• Conduct regular audits to ensure that the sample pulling and testing processes are carried out in accordance with established protocols. 
• Use testing results to assess and confirm product quality and compliance with regulatory requirements.

OTHER REQUIREMENTS 

Experience/Knowledge Required:

• Preferred industry experience (cosmetics, pharmaceuticals).
• Strong communication and attention to detail.
• Understanding of Good Manufacturing Practices (GMP).
• Adaptability in the Australian manufacturing environment.

Technical Capability:

• Intermediate proficiency in Excel, Outlook, and MS Word.

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