QC Microbiology Analyst 1

Biofire Diagnostics - Durham, NC

Full-time - Entry Level

Durham, NC

Computer and Electronic Product Manufacturing

About the position

The QC Microbiology Analyst 1 role is responsible for routine microbiology testing in a fast-paced, FDA regulated environment within the Medical Devices/Diagnostics Industry. This position involves the preparation and testing of finished product samples, stability samples, and special test requests, as well as documentation and contributions to Continuous Improvement initiatives. The analyst will perform testing for Growth Performance, Antimicrobial Neutralization, and Contamination Checks in the QC Microbiology laboratory.

Responsibilities

• Perform routine microbiology testing including preparation and testing of finished product samples, stability samples, and special test requests.
• Culture and manipulate microbes using aseptic techniques and microbiological testing protocols.
• Document all testing accurately and thoroughly in compliance with procedures and GDP requirements.
• Review laboratory testing in compliance with SOPs and ensure timely completion.
• Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
• Prepare for regulatory, customer, and internal audits of microbiology laboratory areas.
• Provide input for laboratory investigations and document invalid test results as per procedures.
• Enter data into the laboratory information management system (LIMS) and assist with LIMS maintenance and validation activities.
• Ensure personal training on current department processes and procedures is maintained.
• Utilize PPE appropriately for routine and non-routine laboratory duties.
• Participate in continuous improvement activities and maintain laboratory organization in compliance with cGLP.

Requirements

• Bachelor's degree with 0 years of experience required.
• High school diploma/GED with 4+ years of experience in a regulated laboratory environment, or an Associate's Degree with 2+ years of experience in a regulated laboratory environment accepted.
• Lab experience in Environmental Monitoring and Microbiology is highly desired.
• BS degree in Biology or Microbiology is preferred.
• Technical and scientific knowledge of microbiological laboratory techniques, testing, and quality principles (GMP/GLP) preferred.
• Experience with software tools for data entry and analysis (LIMS); technical writing skills preferred.
• Strong organizational skills and ability to prioritize work and manage multiple tasks independently.
• Excellent verbal and written communication skills; teamwork orientation.
• Ability to problem solve/troubleshoot and provide solutions with minimal supervision.
• Ability to proactively identify opportunities for improvements and provide suggestions.

Nice-to-haves

• Lab experience in Environmental Monitoring and Microbiology
• Technical writing skills
• Experience with LIMS software