Job Description

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.

– 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, 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.

Requirements

Minimum of 5 – 6 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.

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