Microbiologist II

Curia • Albuquerque, NM

2d • Onsite

About The Position

Curia is a global contract development and manufacturing organization (CDMO) that partners with pharmaceutical and biotechnology companies to provide treatments to patients. The Quality Control Microbiologist performs quality activities supporting product production and release, ensuring compliance with applicable regulatory requirements through testing, trending, and reporting results. The position is in Albuquerque, New Mexico.

The role performs microbiological testing and environmental monitoring; reads, trends, and reports testing results; and supports investigations and general QC microbiology laboratory activities. It also includes responsibilities for controlled documents, SOP reviews, reports, project oversight, and the Change Control System.

The employee must pass a background check and drug screen. The work involves laboratory and cleanroom settings, with occasional exposure to various workplace hazards and moderate noise. Physical duties include regular communication, frequent sitting and hand use, occasional standing and movement, and lifting loads up to 50 pounds. Duties may be modified to reasonably accommodate individuals with disabilities.

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.
• Computer skills, including proficiency 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 and 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 endotoxin and bioburden testing for water, and endotoxin, sterility, and bioburden testing for raw materials, in-process materials, intermediates, and final products.
• Perform cleanroom 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 laboratory media, and microbial limits/enumeration testing.
• Receive, log in, process, track, and distribute results for QC microbiological samples, and close out the sample process.
• Initiate out-of-specification (OOS) or environmental-monitoring-excursion investigations.
• Support general QC Microbiology Laboratory activities, including chart reading and changing, equipment cleaning and maintenance, supply and inventory maintenance, and 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.
• Perform other job-related duties as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level