Quality Control Microbiologist

Company: AMRI ( Learn More )

General Information
US-MA-Burlington
N/A
4 Year Degree
Full-Time
At least 5 year(s)
Not Specified
False
False
Job Description

The Quality Control Microbiologist performs quality activities in support of product production and releases.  The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.    

Position Responsibilities
Other duties may be assigned

  • Perform microbiological testing (endotoxin, bioburden) for water.
  • Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product.
  • Perform environmental monitoring of the clean rooms (under ISO and EU specifications).
  • Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results.
  • Perform microbial characterization (gram stain, catalase, oxidase, and couagulase tests)
  • Prepare and send out samples for microbiological identification
  • Maintain historical files on organisms found in classified areas; microbial identification and trending.
  • Perform line clear and line start verifications
  •  Inspection of media fills.
  • Perform other microbiological assays:
  • Sterility ( including Biological Indicator testing)
  • Growth promotion testing of all incoming media used in the microbiology   laboratory.
  • Preservative Effectiveness testing
  • Microbial Limits testing
  • QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure.
  • Initiate OOS/OT  or Environmental Monitoring Excursion Investigations
  • Provide Support of general QC Microbiology Laboratory activities
  • Chart reading and changing
  •                 Equipment cleaning and maintenance
  • Maintaining supplies and inventory
  • General laboratory housekeeping 
  • Job Requirements

    Education: Bachelor’s degree in scientific discipline required; microbiology strongly preferred

    Relevant Work Experience:  5+ years’ industry experience in a GMP,GLP, or pharmaceutical clean room environment

    Knowledge, Skills & Abilities:

    •         Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus.

    •         Strong organizational skills and the ability to prioritize/multitask

    •         Proficient in Microsoft Office Suite (excel)


    Shift:  First Shift