16287244-QC Micro Analyst II-Dublin Contractor

This is a 12-month contract.

Purpose:

The QC Microbiology Specialist is responsible for technical and quality oversight for activities within the QC Microbiology department. The Specialist will provide technical support with regard to method verification, Environmental Monitoring, Utilities and all other lab-based activities

 Responsibilities:

• Support validation/verification and qualification of test methods and processes.
• Troubleshoot laboratory methods and instrument issues as they arise.
• Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
• Investigate out-of-specification/limit results utilizing Structured Problem Solving, and Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions.
• Lead and participate in Quality Risk Assessments relating to QC.
• Technical report writing in support of routine testing and method verifications.
• Perform technical review of data generated in laboratory, validation protocols and reports.
• Represent the QC department in internal and external audits where appropriate.

Minimum Qualifications & Requirements:

• Degree in Science/ Microbiology or related science.
• Minimum of 5 years of experience in cGMP Quality environment.
• Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
• Good knowledge of current regulatory requirements for QC / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing
• Experience in Quality Risk Management.
• Excellent knowledge of LIMS.