Sterility Assurance Specialist

About the company

Walker Cole International is supporting a well-established healthcare and life sciences organisation in the search for a Sterility Assurance Specialist to join their Quality team, based in the East Midlands.

Your tasks

This is an excellent opportunity to take ownership of sterility assurance within an aseptic compounding unit, protecting patients by ensuring products are manufactured in a compliant, well-controlled environment. Reporting to the Head of Quality, you will be the site’s technical expert on sterility assurance and environmental monitoring. The role offers broad exposure across investigations, microbiological data trending, validation, external laboratory oversight and aseptic training.

You will be responsible for

• Ensuring effective sterility assurance and environmental monitoring programmes are in place and compliant with current GMP.
• Leading and supporting investigations into product and process deviations, complaints, nonconformances and quality incidents, acting as technical approver.
• Interpreting microbial identification and environmental monitoring data, trending EM and microbiological results and setting appropriate alert limits.
• Providing expert guidance on sterility assurance questions, including risk reduction initiatives and the introduction of new microbiological testing and environmental control technology.
• Carrying out validation and experimental design activities in partnership with the EMEA Sterility Assurance Manager.
• Qualifying, auditing and monitoring the service levels of external laboratories, providing technical oversight.
• Tracking and reporting quality metrics for internal and external use.
• Supporting the development of quality documentation, including local SOPs.
• Delivering microbiological and aseptic operator training for operational and quality staff, including periodic reassessments.
• Coaching other functions in problem solving and contributing to continuous improvement projects.

Requirements

This role would suit a microbiology or sterility assurance professional with at least three years’ experience running environmental control programmes in an aseptic or GMP manufacturing environment, looking to step into a technical expert role.

The successful candidate will have

• A degree in Microbiology, or a related discipline with relevant experience.
• At least three years’ experience implementing environmental control programmes and investigating and correcting out-of-limit (OOL) results; five years’ microbiology experience in an aseptic facility is preferred.
• Strong operational experience, ideally within aseptic manufacturing, and hands-on experience of aseptic technique.
• Experience of change control for critical equipment and processes, and of validating microbiological methods or sanitisation processes.
• Experience with quality improvement and problem-solving tools such as FMEA, DMAIC and process mapping, along with Lean manufacturing and data interpretation.
• Excellent communication and interpersonal skills, with the ability to work autonomously, think critically and make sound decisions.

Other

Sterility Assurance Specialist | Sterility Assurance | Microbiology | Microbiologist | Environmental Monitoring | EM | Aseptic | Aseptic Compounding | Contamination Control | GMP | OOL | OOS | Deviations | Investigations | Validation | Sanitisation | Quality Assurance | Pharmaceutical