Job Description

Job 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. They
will oversee the operation of a QC testing group by means of a hands-on
approach to laboratory operations.

Job 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, 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

Experience:

   • 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.

   • Degree in
Science/ Microbiology or related science.