job summary :
The Sr Microbiologist supports management of laboratory operations, quality actions, lab testing, and data review associated with production facilities.
In addition, the job holder has expertise in QC Microbiology, and provides guidance, training, and sharing of knowledge to personnel within the group and across departments.
responsibilities :
- Responsible for QC lab testing and data review.
- Lead the team and arrange team responsibilities as needed.
- Leads and / or serves on team projects as needed.
- Writes, reviews, and approves microbiological lab investigations, deviations, change controls, protocols, reports.
- Writes, updates, reviews, and approves Laboratory Standard Operating Procedures, Work Instructions, and References.
- Assures that laboratory equipment is calibrated and in good working condition, purchases supplies and equipment.
- Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP’s, GMP’s and regulations and Microbiological SME for internal and external regulatory audits and inspections.
qualifications :
- Minimum Level of Education Required : BA / BS in a scientific discipline is required; BS / MS in Microbiology or Biology is preferred.
- Minimum Level of Job-Related Experience Required : B.S. with 2+ year’s industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience.
- The job holder should have strong knowledge of biological and microbiological principles to apply them directly to the work performed in QC Microbiology and to provide a scientific resource to other departments.
- This position requires knowledge of microbial assays, environmental monitoring and clean utility sampling and testing in a cGMP environment
- Other Required Experience : Experience in industrial microbiology, with specific expertise in at least one area of microbiology testing.
skills :
Quality control, SOP, Biology, Microbiology
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