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Microbiology Analyst II

Ocular Therapeutix, Inc.
Bedford, Massachusetts, US
Closing date
May 20, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Perform QC activities such as Environmental Monitoring of the manufacturing facility, microbiological/biological testing of products (e.g., bioburden, endotoxin), and performing sample receipt and send outs. This position also supports EM trend reports, EM excursions investigations and data review.

Perform environmental monitoring - sampling of clean roomsPerform sampling of RODI Purified Water SystemCoordinate shipment of samples to contract laboratoriesReceive test results/data from contract laboratories and perform data review and entry into the appropriate databaseConduct routine analysis of microbiology methods in accordance with standard operating procedures (SOPs) or compendial methods (Bioburden, Endotoxin).Assist with data trending and aid in compilation of trend reportsAssist with EM excursion investigationsAssist with the preparation of EM excursion reportsWork on individual projects independently with supervisionCompletes QC documentation in accordance with cGMPManage time effectively to complete assignments in expected time frameSample disposal upon completion of testingParticipate in laboratory housekeeping choresPerform other related duties and tasks as required or assigned

Qualification Requirements:Bachelor's degree in the Life Sciences preferred2-3 years of experience in pharmaceutical or medical device industryUnderstanding of aseptic techniques and microbiology test methodologiesKnowledge and understanding of GMP, compendial test requirements.Experience with USP and LIMS a plusExperience qualification bioburden and endotoxin testing methods on medical devices preferred.Strong communication skillsComputer literacy, proficiency in MS Office, Excel, PowerPoint, etcAbility to lift 25 pounds Working Conditions:Mix of office and laboratory/clean room environments
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