QC Specialist, Microbiology

​​Position Summary ​

• ​​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.​

​​Principal Responsibilities​

• ​​Support validation/verification and qualification of test methods and processes.

• ​Lead in New Product Introduction and validation strategies

• ​Generating validation and utility reports

• ​Testing of routine and validation samples for Endoxtoxin and Bioburden

• ​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.

• ​Perform technical review of data generated in laboratory, validation protocols and reports.

• ​Represent the QC department in internal and external audits where appropriate.

• ​Close out of actions/ recommendations identified from both internal and external audits.

• ​Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.

• ​To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.

• ​Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.

• ​To keep management updated on issues arising within the laboratory.

• ​Scheduling of testing, review and authorization of microbial data.

• ​To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.

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• ​​Qualifications​

• ​​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.

• ​The duties of this role are generally conducted in an lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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​​Education​

• ​​Degree in Science/ Microbiology or related science.

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