This is what you will do:
The QC Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water sampling, TOC, Bioburden and Endotoxin.
You will be responsible for:
Environmental and Facilities monitoring sampling and testing.
Testing to support release and stability programs on site.
Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
To keep management updated on issues arising within the laboratory.
Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
Qualifications:
Minimum of 1 year experience in cGMP Quality environment.
Experience in testing of sterile/non-sterile pharmaceutical /biopharmaceutical products.
Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
Degree in Microbiology or related science.
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 accommodation to: lift/carry ***** pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer;
Date Posted
19-Mar-****
Closing Date
01-Apr-****
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.
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