Job description

Our Client, A leading Medical Device Company, based in Limerick, are hiring for a Microbiology Analyst.

Role & Responsibilities:

• 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 minimizing 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.

Requirements:

• Good knowledge of FDA and ISO requirements
• Good organization skills and familiarity with computer packages.
• Level 8 in Microbiology discipline or similar required.

Job Type: Full-time

Schedule:

• 8 hour shift
• Day shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Limerick, CO. Limerick: reliably commute or plan to relocate before starting work (required)

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