We are seeking a full-time Quality Assurance Aseptic Associate role based in Perth, WA. The Aseptic Associate will be responsible for integrating, improving and implementing aseptic techniques and microbiological processes within the pharmaceutical industry. This role focuses on developing and optimising microbiological controls, environmental monitoring, and aseptic processes in the sterile manufacturing facility, ensuring compliance with regulatory standards. This position requires strong expertise in microbiology, aseptic, project management skills, and the ability to collaborate with cross-functional teams to introduce new processes and establish robust contamination control practices.

HOW WILL YOU QUALIFY?

• Bachelor’s or Master’s degree in Microbiology, Biology, Biotechnology, or related scientific discipline.
• 3+ years of experience in microbiology and aseptic processing
• Strong knowledge of regulatory guidelines (GMP, FDA, EMA) in the context of aseptic and microbiological processes.
• Ability to manage multiple projects and adapt processes to new client requirements.
• Excellent problem-solving skills, with a focus on contamination risk assessment and mitigation.
• Strong communication and client-facing skills to explain technical concepts clearly and build client confidence.

• Supports the manufacturing team and manufacturing shifts to ensure maintenance of cGMP throughout normal business and through change. Including assisting in identifying and solving quality assurance problems in the plant and after-hours attendance at site to support aseptic oversight activities.
• Oversee the integration of aseptic techniques into manufacturing processes, ensuring sterile conditions are maintained.
• Develop procedures for aseptic processes and ensure training for operational staff to meet site needs.
• Support the scale-up of aseptic operations, providing guidance on contamination risk and mitigation strategies.
• Audit, Improve and Maintain the environmental monitoring program to meet the demands of the facility.
• Design and implement new monitoring protocols for cleanroom environments and aseptic areas, ensuring regulatory compliance.
• Review environmental data and trends to proactively address contamination risks.
• Develop and implement microbiological testing protocols (e.g., sterility, bioburden, endotoxin).
• Ensure timely and accurate microbiological testing and regulatory compliance.
• Review and analyse test results, providing data-driven insights to internal teams regarding product quality and safety.
• Collaborate with project teams and new clients to understand specific microbiological requirements for their product pipelines.
• Act as the subject matter expert (SME) for aseptic processing and microbiological concerns during project scoping, ensuring the client’s requirements align with internal capabilities.
• Ensure all new aseptic and microbiological processes comply with industry standards and regulatory requirements (e.g., GMP, FDA, EMA) from project initiation to completion.
• Lead the design and implementation of new aseptic processes, tailored to the needs of new clients and projects.
• Work closely with process development and production teams to establish microbiological control points for new product lines.
• Validate new aseptic processes, cleanroom environments, and microbiological testing methods according to regulatory guidelines (GMP, FDA, EMA), including Media Fills.