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

Ally Nutra

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