Quality Control Analyst

Role Overview

We are seeking a Microbiology/Biology Quality Control Analyst to perform both routine and non-routine microbiological and biological testing to support product release, raw materials, environmental monitoring, and stability programs. The ideal candidate has hands-on experience with core microbiology techniques—especially microbial identification, endotoxin (LAL), sterility testing, bioburden, and preservative efficacy testing—and can confidently explain testing principles, workflows, and troubleshooting steps.

This position requires strong technical execution, documentation accuracy, and the ability to collaborate across QC, R&D, vendors, and contract labs.

Key Responsibilities

• Perform microbiological and biological analyses of raw materials, in-process samples, finished products, and environmental samples.
• Conduct core microbiology testing including sterility, bioburden, microbial identification, preservative efficacy testing (PET), and endotoxin (LAL).
• Ensure laboratory cleanliness, biosafety compliance, and proper handling of biological materials.
• Develop, qualify, validate, and transfer biological and microbiological test methods.
• Troubleshoot issues with testing equipment such as incubators, autoclaves, biosafety cabinets, and other biological instruments.
• Train analysts on microbiological and biological assays.
• Perform visual inspections of samples and finished products for contamination or abnormalities.
• Participate in internal audits, contamination investigations, and OOS/OOT review.
• Write and revise technical documents including protocols, test methods, deviations, microbial trend reports, and SOPs.
• Review data from internal and contract labs for accuracy and regulatory compliance.
• Maintain and calibrate microbiology lab equipment; complete equipment logs and testing records.
• Compile test results, perform statistical analyses, and support data for regulatory submissions.
• Evaluate and recommend new microbiology and biological testing technologies (PCR, ELISA, flow cytometry, cell-based assays).
• Act as a technical liaison with vendors, contract labs, and cross-functional partners.

Required Skills & Experience

• Hands-on experience with microbial identification, sterility testing, bioburden, LAL, and/or preservative efficacy testing.
• Strong understanding of microbiology testing workflows and ability to clearly explain methods during interviews.
• Experience in a regulated QC, microbiology, or biological testing environment.
• Ability to perform method development, qualification, troubleshooting, and equipment maintenance.
• Strong technical writing, documentation, and GMP compliance skills.
• Ability to work cross-functionally and communicate results clearly.

Preferred Qualifications

• Experience with method transfers or validations.
• Familiarity with environmental monitoring programs.
• Experience supporting regulatory submissions with QC data.
• Prior experience reviewing data from contract testing labs.