What does this job involve?
- The Microbiology Analyst will be responsible for microbiological testing, method transfers and verification, sample and data management and equipment maintenance.
- Perform analytical testing as a main priority with efficiency and accuracy
- Responsible for planning and performing multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- The Microbiology Analyst will troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Write protocols and perform assay validation and equipment qualification/verification.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
What should you have?
- Bachelor’s degree in a science discipline with Biopharmaceutical QC experience in a microbiology lab
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
- Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Experience in LIMS, Change Control, Trackwise, SAP and EDMQ an advantage
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