QC Microbiologist -Bioburden, Endotoxin Position Available In Lee, North Carolina

QC Microbiologist -Bioburden, Endotoxin Unity Health 1599 1599 J, Sanford, NC 27330 Job description

Job Summary:

We are seeking a dedicated QC Microbiologist with hands-on experience in bioburden and endotoxin testing to support quality control activities in a cGMP-compliant microbiology laboratory. The successful candidate will be responsible for ensuring that all microbiological testing related to product safety, sterility, and compliance is performed to regulatory and internal standards.

Key Responsibilities:

Perform bioburden testing on raw materials, in-process samples, and final products in accordance with USP , , and applicable ISO standards (e.g., ISO 11737). Conduct endotoxin testing using LAL assays (gel clot, chromogenic, or turbidimetric methods) per USP . Prepare and maintain sterility of media, reagents, and equipment for microbiological testing. Execute microbial limits tests and assist in microbial identification procedures as required. Document all activities clearly and accurately in laboratory notebooks, logbooks, and electronic systems, in compliance with GMP and GLP standards. Participate in environmental monitoring programs, cleanroom qualification, and utility testing (e.g., purified water, compressed air). Support deviation investigations, out-of-specification (OOS) results, and implementation of corrective and preventive actions (CAPA). Assist with method validations, qualifications, and routine instrument calibration and maintenance.

Qualifications:

Bachelor’s degree in Microbiology, Biology, or a related life sciences field. 1-3 years of experience in a microbiology laboratory within the pharmaceutical, biotechnology, or medical device industry . Proficient in bioburden and endotoxin testing following USP, EP, and FDA guidelines. Experience using LAL assay systems (e.g., Endosafe, Charles River, or similar platforms). Familiarity with aseptic technique, gowning procedures, and cleanroom protocols. Excellent documentation and organizational skills. Knowledge of

GMP , GLP

, and applicable regulatory requirements.

Preferred Experience:

Experience in environmental monitoring (viable and non-viable particulate monitoring). Familiarity with microbial identification techniques (e.g., Gram staining, MALDI-TOF, biochemical tests). Prior involvement in audit readiness or supporting regulatory inspections.

Experience:

Microbiology:

3 years (Required) bioburden: 3 years (Required) endotoxin: 3 years (Required)

Job Type:

Contract Pay:

$50.00 per hour Expected hours: 40 per week

Schedule:

8 hour shift Day shift Monday to

Friday Work Location:

In person