Quality Associate - Aseptic Sme

Salary: 80.00 -  100.00
Posted: 04-02-2025
Category: Quality Management Operations

Job Description

About the Company : Our client is a well-known pharmaceutical company based in the eastern suburbs of Perth. They are currently looking for a skilled Quality Associate - Aseptic SME to work on various projects, ensuring that processes, equipment, and systems meet regulatory, quality, and safety standards. The role is a 12-month contract with the potential to extend. The Role : Your responsibilities will include, but are not limited to : Act as the subject matter expert (SME) for aseptic processing and microbiological concerns in relation to the project. Lead the design and implementation of new aseptic processes (including CCP identification) and monitoring protocols for cleanroom and aseptic areas. Validation of processes, cleaning, and testing methods. Develop and implement microbiological testing protocols (e.g., sterility, bioburden, endotoxin) and SOPs for new aseptic processes. Providing training/coaching and support to other team members. Review and analyse microbiological test results. Support the scale-up of aseptic operations, providing guidance on contamination risk and mitigation strategies. Skills & Experience : To be successful in this position you will have : Bachelor’s or Master’s degree in Microbiology, Biology, Biotechnology, or related scientific discipline. A minimum of 3 years of experience within microbiology and aseptic processing, with a focus on new project and process development. Proven experience in supporting new client projects, from initiation to process validation. Good written and verbal communication skills. Ability to form resourceful relationships. Good numeracy skills. Project management skills including problem-solving skills. Strong attention to detail. How to Apply : Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume in WORD format (PDFs can be corrupted/not processed). Note: Applications only accepted from Australian/NZ residents with valid Australian work rights or temporary residents on work visas e.g., Working Holiday Visa. #J-18808-Ljbffr

Job Details

Salary: 80.00 -  100.00
Posted: 04-02-2025
Category: Quality Management Operations

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