QC Microbiologist

ALLIANCE BIOTECH SOLUTIONS LLCRaleigh, NC
Onsite

About The Position

Alliance Biotech Solutions is seeking a dedicated QC Microbiologist to support Environmental Monitoring (EM) and microbiological testing activities within a GMP manufacturing environment. This role is responsible for performing routine environmental monitoring in controlled manufacturing areas and executing microbiological testing within the QC laboratory. The ideal candidate will have hands-on experience collecting environmental samples in cleanroom environments and performing laboratory testing such as bioburden and endotoxin analysis. This position requires a strong understanding of aseptic techniques, GMP documentation practices, and microbiological testing methodologies.

Requirements

  • Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related life sciences field.
  • 4-5 years of QC Microbiology experience in a pharmaceutical or biotech GMP environment.
  • Hands-on experience performing Environmental Monitoring activities, including viable air, surface, personnel, non-viable particulate, gas, and clean steam sampling.
  • Experience performing microbiological testing such as bioburden, endotoxin, microbial enumeration, and related QC lab assays.
  • Comfortable working independently in cleanroom environments for extended periods.
  • Knowledge of GMP, GLP, and aseptic processing practices.
  • Excellent communication and teamwork skills.
  • Ability to work in classified cleanroom areas, follow aseptic techniques, and perform routine monitoring activities.

Responsibilities

  • Perform environmental monitoring activities including non-viable particulate monitoring, viable air sampling, surface monitoring, personnel monitoring, gas sampling, and clean steam sampling.
  • Collect environmental samples within ISO classified manufacturing areas while adhering to GMP and aseptic practices.
  • Transport, document, and process environmental monitoring samples in accordance with approved procedures.
  • Perform routine microbiological testing including bioburden, endotoxin, and other QC microbiology assays as required.
  • Prepare media, reagents, and laboratory materials necessary for environmental monitoring and microbiological testing activities.
  • Incubate, read, enumerate, and document microbiological test results and environmental monitoring data.
  • Support investigations related to environmental monitoring excursions, out-of-specification results, deviations, and contamination control activities.
  • Maintain laboratory and monitoring equipment, complete GMP documentation, and support cleanroom qualification and utility monitoring programs.

Benefits

  • Industry competitive wage as a full-time employee
  • Flexible Paid Time Off
  • Medical, Dental and Vision Insurance with low employee cost
  • Employer paid long term and short-term disability
  • 401k plan with employer contributions
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