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QC Associate I/II, Microbiology

Employer
Medix
Location
Waltham, Massachusetts, US
Salary
Competitive
Closing date
Sep 27, 2021

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
The Role:

The QC Associate II, Microbiology is responsible for performing routine testing and project work in the QC microbiology laboratory at our Waltham facility. Second shift hours are most urgent openings!

Here's What You'll Do:
  • Conducts environmental monitoring sampling of manufacturing cleanroom areas and utility systems (WFI and Compressed gases)
  • Perform QC microbiological assays such as: appearance, bioburden, endotoxin, sterility, and TOC/Conductivity assays.
  • Accurately records, summarizes, trends and reviews data in accordance with cGMPs and SOPs
  • Perform investigations and execution of method qualifications
  • Draft validation protocols and reports
  • Author and revise SOPs and training documents
  • Generate and present trend data/reports
  • Coordinate data for batch release
  • General Housekeeping of laboratories
  • Conduct training

Requirements:
  • Bachelor's degree in technical discipline (Microbiology/Biology or related field) with 3 to 5 years of experience in a GMP manufacturing facility
  • Advance knowledge of microbiological compendial methods and techniques such as but not limited to: subculturing, Gram Stain, Aseptic Techniques, Aseptic Gowning, operation in biological safety cabinets, rapid microbiological methods
  • Ability to lift 25 lbs. and pass aseptic gowning qualifications
  • Ability to gown and work in cleanroom environment
  • Ability to communicate and manage projects with minimal guidance
  • Experience conducting and writing up laboratory and environmental monitoring investigations
  • Experience designing lab experiments, drafting of validation protocols and reports
  • Experience analyzing data and trends using statistical software
  • Ability to train others on methods and routine lab work
  • Excellent organizational and time management skills.
  • Knowledge of word, excel, PowerPoint, laboratory data analysis systems (LIMS) preferred.
  • Experience in cell and gene therapy manufacturing environment a plus

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