QC Senior Specialist, Microbiology

Found in: Talent IE C2 - 2 weeks ago

Dublin, Ireland Alexion Pharmaceuticals Full time

Position Summary

The QC Microbiology Senior Specialist is responsible for technical and quality oversight for activities within the QC Microbiology Dept. The Senior 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 skills.

Job Duties and 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 Senior Manager, QA and other relevant departments and to implement effective corrective and preventative actions. Lead and Participate in Quality Risk Assessment relating to QC Technical report writing in support of 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 The duties of this role are generally conducted in a lab environment. As is typical of a lab based role, employees must be able, with or without an accomodation 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 though, analysis, and dialogue; collaborate with others; maintain general availabiity during standard business hours.

Qualifications

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 Exerience in Quality Risk Management Excellent knowledge in LIMS

Preferred Qualifications

Experience of Trackwise, Empower and documentation systems would be an advantage. Project management skills. Excellent written and verbal skills and strong interpersonal skills High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint. 

Date Posted

28-Mar-2024

Closing Date

24-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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