QC Specialist, Microbiology at AstraZeneca

Dublin, Leinster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

31 Dec, 25

Salary

0.0

Posted On

02 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Microbiology, Method Verification, Environmental Monitoring, Aseptic Filling, Regulatory Compliance, Quality Risk Management, LIMS, Technical Support, Problem Solving, Training, Data Review, Project Management, Root Cause Analysis, Validation, Bioburden Testing

Industry

Pharmaceutical Manufacturing

Description

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. 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. Education Degree in Science/ Microbiology or related science. Date Posted 02-Oct-2025 Closing Date 02-Oct-2025 Our 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. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Responsibilities

The QC Microbiology Specialist is responsible for technical and quality oversight within the QC Microbiology department, providing support for method verification and laboratory operations. They will lead validation strategies, troubleshoot laboratory methods, and ensure compliance with regulatory requirements.