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Microbiology Analyst

  • Job reference: 925062
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 24/04/2019

Orion Group are recruiting a Microbiology Analyst on behalf of our Multinational Medical Device Client on an initial 12 month contract based in Limerick.

Job Purpose:

The Scientist 1 Micro and Scientist 2 Micro roles are responsible for assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures.

2. Responsibilities:

List main areas of responsibility:


− Perform routine environmental monitoring, product testing in line with company and regulatory specifications and trend associated data
− Perform routine testing on water purification systems in line with company and regulatory specifications and trend associated data
− Perform Quality Control on incoming media and test kits.
− Perform microbial identifications to ensure compliance with procedure and regulatory requirements
− Perform validation and annual re-qualification of production Sterilisers and calibration of Validation equipment and document-associated data
− Complete Annual re-qualification of laboratory Steriliser.
− Perform Process / Equipment / Facilities and Utilities Validation and document associated data
− When required, Review and report Steriliser Non-conformances
− Perform monthly run review of production sterilisers performance using statistical tools
− Implement improved methodologies/processes for Lab processes
− When required Perform microbiology assessment on engineering changes
− Carry out safety inspections
− Training of new microbiology laboratory technicians
− Providing Japan Distribution with Sterility Certificates for product
− Ensure Lab is supplied with consumables.
− All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
− Creating, implementing and assessing change requests.
− Sterilizing and disposing of laboratory waste.


3. Education and Experience Required for Role
Essential:
− Minimum of Certificate level qualification preferably in Microbiology or Biological Sciences.
− At least 1 years industrial experience in the Pharmaceutical/Medical Devices Industry
− Good knowledge of FDA and ISO requirements
− Good organization skills and familiarity with computer packages.


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.