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SENIOR STERILIZATION ASSURANCE SCIENTIST

  • Job reference: 921618
  • Location: Blackpool, Lancashire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 11/09/2018

Orion Group are recruiting a Senior Sterilization Assurance Scientist on behalf of our Multinational Medical Device Client Located in Lancashire

The purpose of this role is to be the company's expert on the application and practice of microbial assurance as applied to the design, manufacture and sterilization of implants while ensuring that the company meets all Corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.

ESSENTIAL:

  • Degree level qualification in Microbiology or equivalent.
  • Minimum 5 years post qualification experience (5 years with BSc, 3 years with MSc and 0-2 years with PhD) as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
  • Familiarity with microbiological aspects of GMP regarding sterile medical devices.
  • Experience ofconducting GMP audits, internal and relevant external audits.
  • Must have the initiative and ability to investigate, plan and execute those actions required to
  • constantly improve and develop the company's microbial assurance levels.
  • An organized and logical approach to training, documentation, and audit requirements is also essential.
  • A professional approach, when dealing with internal, corporate, regulatory or supplier representatives is also required.
  • DESIRABLE: ISO 9001 Lead Assessor qualification.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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