The Microbiologist is expected to follow all policies and procedures which include but are not limited to; Standard Operation Procedures (SOPs), Work Instructions (WI), current Good Manufacturing Practices (cGMPs), and current Good Laboratory Practices (cGLPs).
1) Perform routine Microbiological testing/data analysis which includes, but is not limited to:
• Bioburden testing for In-Process Drug Products, Raw Materials (API), Water for Injection (WFI), City Water, and Reverse Osmosis Water (RO) to assess potential microbiological contaminants.
• Total Organic Carbon (TOC), Conductivity, and Endotoxin testing on Water for Injection (WFI) and Clean Steam samples.
• Perform sterility testing of Aseptic and Terminally Sterilized products.
• Perform Microbiological Organism Identifications to the genus and species level.
• Perform Growth Promotion/Quality Control Testing of Microbiological media and/or materials used for Microbiological sampling and testing.
• Read plates generated from Environmental Monitoring and Microbiological Laboratory testing.
2) Operate an Autoclave to perform sterilization and decontamination cycles and equipment, media, and biohazard waste.
3) Author and revise procedures, including but not limited to Standard Operating Procedures (SOPs), Work Instructions (WI), and Forms.
4) Complete Deviations, Change Requests (CRs), and Corrective and Preventative Action Plans (CAPAs) as instructed by Microbiology Management.
5) Assist with writing/executing Microbiology Method Validations.
6) Review and generate reports as requested by Microbiology Management (i.e. Product Release and Data Trending).
7) Perform daily and weekly laboratory cleaning requirements.
8) Disposal of hazardous waste and non-hazardous waste following applicable EHS training.
9) Perform duties and responsibilities as requested by Microbiology Management.
Additional Job Responsibilities
1) Perform sampling of Water for Injection (WFI), City Water, Reverse Osmosis Water (RO), and Clean Steam to support manufacturing and/or qualification activities.
2) Perform Personnel Monitoring of sterile garbed personnel.
3) Perform Compressed Air and Compressed Gas sampling to support manufacturing and/or qualification activities.
4) Perform Viable Air, Total Particulate Air (Non-Viable), Surface (RODAC), and Swab sampling to support manufacturing and/or qualification activities
Microbiology, Assay, CAPA, SOPs, Pharma, FDA, GMP, raw materials, finished products, API, Water for Injection, WFI, Osmosis Water, Bioburden testing, data analysis, contaminants, conductivity, endotoxin, clean steam samples, Total organic carbon, TOC, sterility, sterility testing, aspectic, terminally sterilize, organism identification, growth promotion, quality control, plating, autoclave, deviations, change request, method validation, method development, lab reports, cGMP, cGLP, GLP, viable air, total particulate air, non-viable air, swab sampling, RODAC
Top Skills Details:
Additional Skills & Qualifications:
• Bachelor of Science Degree in Microbiology, Biology, or other related Life Sciences.
• Minimum 3 years of experience in a Microbiology Laboratory (preferably with experience in a GMP Pharmaceutical Manufacturing environment).
• Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment.
• Experience with Microbiological technical writing.
• Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), U.S. Pharmacopeia (USP), and other regulatory requirements.
• Ability to multi-task, work under pressure with time constraints.
• Must be flexible and able to adapt to changes in task priority.
• Excellent communication skills and ability to work independently to complete tasks.
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