Objectives | Purpose
:
Execute microbiological testing in support of but not limited to Environmental/Water/Bioburden monitoring, Media and lab supplies preparation, Sterility Testing and Microbial Identification. Conducts tests for in-process and finished products as well as raw materials using aseptic techniques. Compliance with all applicable procedures and practices to include local and global SOP’s, product test procedures, safety, USP, ISO, GMP, and applicable governmental regulations.
Key Activities/Responsibilities
:
Manufacturing Support through Environmental and Personnel Monitoring. Support Manufacturing operations through Environmental Monitoring. The testing consists of surface testing, employee gowning monitoring, viable air monitoring, and air total particle counts. Media and Lab Supply Preparations. Prepare culture media and supplies needed for test execution. Sterilize supplies and autoclave as required. Maintain the microbiology lab inventory. Perform Growth Promotion Testing and Sterility Verification. Water, Disinfectants, and Pre-Sterilized Product Testing. Execute testing in a Laminar Flow Hood using aseptic technique. Reading Plates and Liquid Media. Execute and document final reading of all microbiological testing. Particulate Matter Testing. Perform finished product testing in a Laminar Flow Hood and accurately document the data. Biological Indicators. Perform testing aseptically in a Laminar Flow Hood to support validation and production. Sterility Isolator Loading. Load the Sterility isolators with appropriate supplies and test samples. Execute the VHP cycle for the loaded Sterility isolators. Sterility Testing. Perform testing of finished product in an isolator. Consumables. Properly receive in ordered media and other testing supplies and document appropriately. Data Review. Review Microbiology data in a timely manner to ensure compliance to procedures, accuracy of data, and adherence to good documentation practices.
Qualifications | Training
:
Education: BS in Biology, Microbiology or related life science
Experience: Previous experience in aseptic manufacturing operations and aseptic laboratory practices highly preferred.
Preferred Skills: Math to include metric conversions and ratios. Computer skills are required (Excel, Word, and other customized systems). Knowledge of basic cGMP and good documentation practices. Technical and scientific writing skills.
Weekend Nights Shift – Saturday, Sunday 6:30p to 6:30am, Monday, Friday 8:30pm 5:00am
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