Quality Control Lab Technician (2nd shift)

Trak GroupCincinnati, OH
Onsite

About The Position

We are seeking a detail-oriented Quality Control Lab Technician to perform laboratory testing and quality checks on production batches, finished products, stability samples, and validation samples. This role helps ensure products meet internal specifications, SOP requirements, and applicable FDA and current Good Manufacturing Practices (cGMP) standards before release. The ideal candidate has a strong chemistry or laboratory background, excellent attention to detail, and experience with analytical testing equipment such as HPLC, GC, and TOC.

Requirements

  • Bachelor of Science degree in Chemistry or a closely related scientific discipline.
  • Knowledge of basic laboratory equipment operation and calibration, including: pH meters, Viscometers, Thermometers, Other standard laboratory instruments
  • Knowledge and proper use of laboratory glassware, including pipettes, burettes, and beakers.
  • Understanding of laboratory sampling and testing procedures.
  • Knowledge of current Good Manufacturing Practices (cGMP).
  • Strong analytical and mathematical abilities.
  • Excellent attention to detail and documentation accuracy.
  • Strong organizational and prioritization skills.
  • Self-motivated with the ability to work independently.

Nice To Haves

  • Working knowledge of HPLC, GC, and/or TOC analytical instrumentation.
  • Previous Quality Control laboratory experience in a manufacturing environment.
  • Experience in an FDA-regulated or GMP-controlled environment.
  • Familiarity with chemical raw materials.
  • Exposure to microbiological testing or environmental monitoring.
  • Experience with stability testing, validation, or special analytical projects.

Responsibilities

  • Test production batches according to established formulas, specifications, and SOPs.
  • Determine and communicate necessary batch adjustments and accurately document changes.
  • Perform testing on finished products, stability samples, and validation samples.
  • Conduct instrumental analyses using HPLC, GC, TOC, and other laboratory equipment.
  • Complete documentation associated with batch approval and product release.
  • Review testing data for trends, discrepancies, and potential quality concerns.
  • Assist with developing and maintaining SOPs and microbiological test methods.
  • Test and approve tankers for loading and unloading and document results.
  • Test products associated with customer complaints and returns.
  • Retest returned products to support release or rejection decisions.
  • Properly store samples and maintain retained sample inventories.
  • Support environmental monitoring, including sample collection and chemical or microbiological testing.
  • Maintain a clean, organized, and properly stocked QC laboratory.
  • Prepare and maintain forms, logs, charts, graphs, and other quality documentation.
  • Support ongoing compliance with FDA and cGMP requirements.
  • Communicate testing requirements, results, and outstanding issues between shifts.
  • Participate in special analytical projects, validation activities, and continuous improvement initiatives.
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