Microbiology Quality Control Specialist I

The Microbiology Quality Control Specialist I is responsible for performing routine microbiological testing, environmental monitoring, and quality control procedures to support the production and release of products in compliance with regulatory requirements (FDA, USP, ISO, cGMP). This entry-level role ensures that laboratory results are accurate, reliable, and documented in accordance with company standards and procedures.

Key Responsibilities

• Perform microbiological testing of raw materials, in-process samples, finished products, utilities (water, air, gases), and environmental monitoring samples.
• Execute assays such as bioburden testing, endotoxin testing, microbial identification, sterility testing, and growth promotion testing.
• Maintain accurate and timely documentation of laboratory activities, results, and deviations in compliance with Good Documentation Practices (GDP).
• Support investigations of out-of-specification (OOS) or out-of-trend (OOT) results and participate in root cause analysis.
• Ensure laboratory equipment is properly maintained, calibrated, and qualified.
• Adhere to laboratory safety protocols and good laboratory practices (GLP).
• Assist with preparation of culture media, reagents, and microbiological supplies.
• Participate in internal and external audits, as needed.
• Contribute to continuous improvement of QC microbiology processes.

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related scientific discipline required.
• 0–2 years of laboratory experience in a microbiology, quality control, or related setting (internship/co-op experience acceptable).
• Basic knowledge of aseptic technique, microbiological assays, and laboratory safety procedures.
• Familiarity with cGMP, GLP, or ISO guidelines preferred.
• Strong organizational skills and attention to detail.
• Ability to work independently and collaboratively in a team environment.
• Effective written and verbal communication skills.

Physical & Work Environment Requirements

• Work performed in laboratory and controlled cleanroom environments.
• May require standing for extended periods and use of PPE (lab coats, gloves, safety glasses, masks).
• Ability to lift up to 25 lbs occasionally.

Growth Opportunity

This is an entry-level position with opportunities for advancement into higher-level QC Microbiology, Quality Assurance, or specialized technical roles as experience and skills develop.