Sterility Assurance Associate

Sterility Assurance Associate
  • £30,000 per Annum
  • Permanent
  • England, UK UK CW7 3RT
Job Ref: J2159068
Sector: Science
Sub-sector: Medical Devices
Date Added: 17 March 2021
Sterility Assurance Associate needed to join a medical device company in Cheshire. Remote working available with this role.

Job Title: Sterility Assurance Associate

Duration: Permanent

Salary: Up to £30,000 per annum (dependent on experience)

Location: Cheshire (Remote working available UK wide)

SRG are working with a leading medical device organisation based in Cheshire who have a requirement for a Sterility Assurance Associate to join their quality team. Due to an increase in workload, this is an exciting new role with opportunities for development and future progression. The purpose of this role is to support all activities related to sterility assurance, providing technical expertise and guidance and support site related activities.


  • Responsible for the representation of Sterility Assurance through all product design and development life cycle phases to ensure product sterility, reliability and cost effectiveness.
  • To determine whether sterilisation methods are acceptable in accordance with applicable regulations and standards for the company's portfolio
  • Ensuring all related QMS processes are kept up to date and with latest versions of applicable standards and industry guidance. Transposition of applicable national/international standards into quality system procedures and implement them across the company's sites.
  • Create and review documentation associated with the Quality System related to sterility assurance, including: quality plans, verification/validation protocols, risk assessment documentations and updates to the Quality System.
  • Support activities associated with the QMS including: Non-conformances, CAPAs SCARs, Audit observations, internal audits and customer complaints.

  • Acts as subject matter expert for Sterility Assurance during external audits (Notified Body, Competent Authority) and supplier audits
  • Attend regular communication meetings with cross-functional teams to identify the root cause of problems and create remedial plans for short-term and long-term resolutions
  • Supports continual improvement projects in accordance with company objectives related to sterilisation requirements


  • BSc or equivalent in a related scientific subject i.e. Microbiology
  • Minimum of 2 years' experience working within a medical device, pharmaceutical, microbiological or food industry.
  • Knowledge of cGMP/cGLP

  • Experience of at least one of the major sterilisation methods i.e. Gamma/EO and application of the applicable ISO standard would be advantageous
  • Knowledge of Medical Device regulations is preferred
  • Lead Auditor trained to ISO 13485 is preferred but not essential

If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to For more information regarding this position or any others, please call Emma on 0161 868 2222.

SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you have a scientific background and this position is not relevant / suitable for you, please feel free to get in touch or visit to view our other vacancies

16/04/2021 13:11:03
GBP 30000.00 Annum
Contact Consultant:
Emma White

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