• QC Microbiology Analyst II

    Job Locations US-MA-Bedford
    Posted Date 4 days ago(9/11/2019 10:40 PM)
    Job ID
    2019-1274
    # of Openings
    1
    Category
    Quality
  • Overview

    We are seeking a skilled Quality Control Analyst II, Microbiology to join our team. Primary responsibility will be lab support activities such as Environmental Monitoring of manufacturing facility, presenting data for review on a routine basis, and performing sample receipt and send outs.

     

    Responsibilities

    • Perform environmental monitoring - sampling of clean rooms
    • Perform sampling of RODI Purified Water System
    • Coordinate shipment of samples to contract laboratories, perform Sample Submission and Receipt, Sample Send outs – prepare samples for shipment to outside contract laboratories Conduct routine and non-routine analysis of microbiology methods in accordance with standard operating procedures (SOPs) or compendial methods
    • Sample disposal upon completion of testing
    • Participate in laboratory housekeeping chores
    • Conduct data entry, Completes QC documentation in accordance with cGMP
    • Assist with data trending and aid in compilation of trend reports
    • Employ good documentation practices to assist in the generation, execution of SOPs and Protocols
    • Update or revise SOPs and other controlled documents as required
    • Work on individual projects independently with supervision
    • Maintain close communication and interaction with QC management and staff to ensure on-time testing
    • Perform other related duties and tasks as required or assigned

    Qualifications

    • BS degree in Microbiology, Biology, Science (or related field)
    • 2-4 years of related laboratory experience in the biopharmaceutical industry
    • Basic understanding of aseptic techniques and microbiology test methodologies
    • Basic understanding of data analysis, statistics, report preparation in MS Word and Excel
    • Knowledge and understanding of GMP, compendial test requirements, USP will be an asset
    • Strong written and oral communication skills
    • Must be able to communicate effectively as well as follow written and verbal instruction
    • Strong collaboration skills as this role will cooperate with coworkers within an organized team environment
    • Manage time effectively to complete assignments in expected time frame

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