QC Microbiology Specialist
This is what you will do:
The QC Microbiology Specialist will be 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, Utiliities and all other lab based activities.
You will be responsible for:
- 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.
- 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.
You will need to have:
- 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.
- Experience in Quality Risk Management.
- Excellent knowledge of LIMS.
- 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.
We would prefer for you to have:
- Excellent problem solving and root cause analysis
- Strong organizational skills
- Excellent written and oral communication skills
- Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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