Quality Control Technician (Microbiology Lab)

Quality Control Technician (Microbiology Lab)

Location: Daytona, FL

Pay Rate: Up to $23/hour

Schedule: Day shift, on-site

Position Overview

This position supports microbiological quality control activities within a regulated medical device/pharmaceutical manufacturing environment. The Quality Control Technician is responsible for performing endotoxin testing, sterility testing, and environmental monitoring (EM) to ensure product safety and compliance with FDA, cGMP, and internal quality standards.

The role requires strict adherence to Good Documentation Practices (GDP) and aseptic techniques while accurately documenting results, identifying deviations, and supporting continuous improvement initiatives within the microbiology laboratory.

Key Responsibilities

Microbiological Testing

• Perform endotoxin testing (LAL), sterility testing, and bioburden testing on raw materials, in-process samples, and finished products
• Execute environmental monitoring (EM) including viable and non-viable sampling (air, surface, and personnel monitoring) within controlled environments
• Maintain aseptic technique and adhere to cleanroom procedures when handling samples and conducting testing
• Prepare media, reagents, and samples in accordance with validated methods and SOPs

Data Analysis & Quality Support

• Record, analyze, and interpret microbiological test results to ensure compliance with specifications and regulatory standards
• Identify and report out-of-specification (OOS), out-of-trend (OOT), and deviation events
• Support investigations by documenting findings and assisting with root cause analysis
• Contribute to continuous improvement efforts by recommending updates to procedures, methods, and lab practices

Documentation & Compliance

• Maintain accurate, complete, and compliant records following Good Documentation Practices (GDP)
• Complete laboratory documentation including test records, logbooks, environmental monitoring data, and batch-related documentation
• Ensure all work is performed in accordance with cGMP, FDA regulations, and internal quality systems
• Assist with SOP revisions, method updates, and audit readiness activities

Safety & Regulatory Compliance

• Follow all laboratory safety procedures, including proper handling of biological materials and hazardous substances
• Maintain compliance with cGMP, cleanroom protocols, and contamination control practices
• Support internal and external audits by ensuring documentation accuracy and traceability

Skills & Knowledge

• Knowledge of microbiology lab techniques including endotoxin (LAL), sterility, and environmental monitoring
• Understanding of cGMP, GDP, and aseptic practices in a regulated environment
• Strong attention to detail with the ability to maintain accurate documentation and data integrity
• Ability to recognize deviations and escalate issues appropriately
• Effective communication skills and ability to work cross-functionally
• Comfortable working in cleanroom environments and following strict procedures

Education & Experience

• Bachelor’s degree in Microbiology, Biology, or related scientific field required
• 1–2 years of experience in a GMP-regulated microbiology laboratory preferred
• Experience with endotoxin testing, sterility testing, or environmental monitoring strongly preferred

Physical Requirements

• Ability to work in laboratory and cleanroom environments (including gowning/PPE)
• Regular sitting, standing, and use of hands for laboratory work
• Ability to lift up to 20 lbs