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QC Microbiology, Analyst I

Marlboro, MA 01752

Posted: 03/12/2025 Employment Type: Contract Job Category: Scientific Job Number: 617804 Is job remote?: No Country: United States

Job Description

This position provides Quality Control Microbiology support to all aspects of a GMP environmental monitoring program and product testing. Looking for experience with environmental monitoring in a GMP setting. Ability/Flexibility to work evenings and weekends is required.    
 
  • Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas/cleanrooms.
  • Perform testing for gram staining/microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation.
  • Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities.
  • Receive samples for analysis, ship samples for contract lab testing, enter/review data, and organize data according to cGDP/GMP requirements.
  • Revise SOPs/forms, and Initiate incident reports for OOS results -support root cause analysis for EM excursions.
  • Assist in EM data review for trending and other technical documentation or projects.
  • Perform lab set up, housekeeping/routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance with cGLP/GMP.


Required:
•    Bachelor’s Degree in biology, microbiology or related life science with 1-2 years’ relevant GMP/pharma/microbiology laboratory experience 
•    Ability/Flexibility to work evenings and weekends/holidays is required- to support manufacturing operations
•    Good knowledge of Aseptic technique and common microbiological testing
•    Knowledge of relevant, compliance and guidance documents, documentation (ALCOA +) and data organization
•    Must be able to gown into cleanrooms in support of testing and manufacturing activities
•    Detail oriented, willingness to learn and follow instructions
•    Interpersonal skills and ability to contribute to the success of a team

Preferred:
•    Experience of working in a fast-paced team environment, time management, and meet deadlines.
•    Team player with the ability and willingness to support other colleagues in the Quality Control department. 
•    Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
•    Organization and completion of assay documentation and entering data into QC database. 
•    Write, revise and review Standard Operating Procedures and Forms.
•    Lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
•    Assist in conducting and documenting laboratory investigations.
•    Participates in facility start-up, commissioning, and validation activities.
•    Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.
•    Perform other lab duties as required
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About Marlboro, MA

Ready to kickstart your career in the vibrant region around Marlborough, Massachusetts? This area boasts a perfect blend of historic charm and modern opportunities, making it an ideal place to grow both personally and professionally. From the picturesque views at Ghiloni Park to the thriving arts scene at the New England Sports Center, there's something for everyone here. Indulge in delicious seafood at the landmark restaurant, Evviva Cucina, catch a performance at the famous New Repertory Theatre, or enjoy a day out at the Solomon Pond Mall. Join us in Marlborough, where endless possibilities await – explore our job listings today and take the next step towards an exciting career in this captivating area!