Microbiologist II

Curia•Albuquerque, NM
•Onsite

About The Position

The Quality Control Microbiologist performs quality activities supporting product production and release, ensuring compliance with applicable regulatory requirements through testing, trending, and reporting. The position supports Curia’s microbiology laboratory and performs testing and monitoring across water, raw materials, in-process materials, intermediates, and final products, including environmental monitoring of clean rooms under USP and EU specifications. The role also includes sample processing and tracking, microbial characterization and identification, investigations, documentation and change control, equipment upkeep, inventory management, and general laboratory housekeeping. The employee may be assigned other job-related duties and instructions. This position is in Albuquerque, New Mexico.

Requirements

  • Bachelor’s degree in a scientific discipline; microbiology is preferred.
  • Three years of previous professional experience.
  • Strong organizational skills and ability to prioritize and multitask in a fast-paced environment.
  • Skilled in computer use and proficient with spreadsheets.
  • Previous experience with pharmaceutical cleanroom environments.
  • Must pass a background check.
  • Must pass a drug screen.

Nice To Haves

  • At least three years of industry experience in a GMP or GLP environment is preferred.
  • Proficiency in validation or qualification of laboratory microbiological techniques is preferred.
  • Knowledge of FDA cGMPs (21 CFR 211).
  • Knowledge of ISO 9001, ISO 13485, and ISO 17025 is a plus.

Responsibilities

  • Perform microbiological testing of water for endotoxin and bioburden, and testing of raw materials, in-process materials, intermediates, and final products for endotoxin, sterility, and bioburden.
  • Perform clean-room environmental monitoring under USP and EU specifications.
  • Read, trend, and report environmental, personnel, in-process, raw material, finished product, and water testing results.
  • Perform microbial characterization, including gram stain, catalase, oxidase, and coagulase tests; prepare and send samples for microbiological identification.
  • Maintain historical files on organisms found in classified areas, including microbial identification and trending.
  • Perform line-clear and line-start verifications and inspect media fills.
  • Perform sterility assays, including Biological Indicator testing, growth-promotion testing of incoming microbiology laboratory media, and microbial limits/enumeration testing.
  • Receive, log in, process, track, and distribute results for QC microbiological samples, and close out sample activity.
  • Initiate out-of-specification (OOS) or environmental monitoring excursion investigations.
  • Support general QC Microbiology Laboratory activities, including chart reading and changing.
  • Clean and maintain equipment, maintain supplies and inventory, and perform general laboratory housekeeping.
  • Facilitate revision and release of controlled documents and mandatory SOP reviews and month-end reports.
  • Provide oversight for projects to update or maintain official document templates.
  • Direct and manage the Change Control System.

Benefits

  • Generous benefit options, eligible from the first day of employment.
  • Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
  • Career advancement opportunities.
  • Education reimbursement.
  • 401(k) program with matching contributions.
  • Learning platform.
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