Quality Assurance Lab Technician

Job Overview

We are seeking a detail-oriented Quality Assurance Lab Technician to join our manufacturing team. In this hands-on role, you will perform analytical testing to ensure products meet the highest standards of quality, safety, and regulatory compliance. You will operate the Soleris microbial detection system, ICP-OES for heavy metal analysis, and HPLC for identity testing, supporting compliance with FDA, ISO 9001, ISO 13485, cGMP, and HACCP standards.

Duties and Responsibilities

• Perform microbial testing using the Soleris rapid detection system (total plate count, yeast and mold, coliforms, E. coli) and interpret results.
• Conduct heavy metal analysis (lead, arsenic, cadmium, mercury) using ICP-OES, including sample digestion and calibration against certified reference materials.
• Run HPLC for identity confirmation and active ingredient verification of raw materials and finished products.
• Perform calibration, preventive maintenance, and troubleshooting on Soleris, ICP-OES, HPLC, and supporting lab instrumentation.
• Test raw materials, in-process samples, and finished products per SOPs, USP/FCC methods, and internal specifications.
• Document results accurately in lab notebooks, LIMS, and batch records following cGMP and data integrity principles.
• Support investigations of out-of-specification (OOS) results, including retests, root cause analysis, and CAPA.
• Prepare reagents, standards, and media; manage lab inventory and hazardous material disposal.
• Assist with internal audits, FDA inspections, and third-party certifications.
• Maintain a clean, safe, and organized laboratory environment.

Qualifications

• Associate's or Bachelor's degree in Chemistry, Microbiology, Biology, Food Science, or related field.
• 1–3 years of lab experience in a regulated manufacturing environment (food, supplement, pharmaceutical, or medical device).
• Hands-on experience with HPLC required; ICP-OES and Soleris (or similar) strongly preferred.
• Working knowledge of cGMP, FDA 21 CFR Part 111/117, ISO 9001, and/or ISO 13485.
• Strong attention to detail, documentation, and problem-solving skills.
• Ability to stand for extended periods, lift up to 30 lbs, and safely handle chemicals while wearing PPE.

Pay: $24.29 - $32.00 per hour

Work Location: In person