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Chemist - Quality Assurance Specialist

2 months ago

Dallas, Texas, United States Apex Systems Full time
Job Summary

We are seeking a highly skilled Chemist to join our team at Apex Systems. As a Chemist, you will be responsible for performing wet chemistry tests in a high-volume working environment for stability testing and quality assurance.

Key Responsibilities
  • Calibrate laboratory equipment as needed to ensure accurate and reliable results.
  • Visually inspect the integrity of container/closure systems to ensure compliance with regulatory requirements.
  • Inspect lot codes/batch codes for correctness to prevent errors and discrepancies.
  • Perform organoleptic and chemical analysis on bulk products, finished goods, raw materials, and stability samples to ensure quality and safety.
  • Proficiently use wet chemistry techniques to analyze samples and provide accurate results.
  • Assess data quickly to identify and report Out-of-Specification (OOS) and Out-of-Trend (OOT) data to ensure timely corrective action.
  • Transcribe raw data to laboratory notebooks and reports of analysis to maintain accurate records.
  • Collect and document retain samples to ensure compliance with regulatory requirements.
  • Request stability samples as needed to support quality assurance efforts.
  • Maintain a log of stability batches to track and monitor product stability.
  • Coordinate with the Quality Control Document Coordinator to ship samples to outsource laboratories as needed.
  • Create stability records as required to support quality assurance efforts.
  • Adhere to laboratory safety standards by following all company safety policies and wearing required personal protective equipment (PPE).
  • Cover other lab personnel as needed to ensure continuity of operations.
  • Update logbooks to maintain accurate records of laboratory activities.
  • Conduct monthly inventory of all reagents and chemicals used in the QC lab to ensure compliance with regulatory requirements.
  • Monitor and maintain chart recorders to ensure accurate and reliable results.
  • Comply with Company Standard Operating Procedures (SOPs) to ensure quality and safety.
Requirements
  • Develop a working knowledge of SOPs, cGMPs, GLPs, ISO, 21 CFR 111, 210, 211, and 117 to ensure compliance with regulatory requirements.
  • Familiarity with the use and function of common laboratory equipment to ensure accurate and reliable results.
  • Ability to work independently as well as in a team environment to ensure effective collaboration and communication.
  • Good visual/observation skills to ensure accurate and reliable results.
Education and Experience
  • Bachelor's degree in chemistry or a related science to ensure a strong foundation in chemical principles and practices.
  • Previous work experience in food, drug, dietary supplement, and/or cosmetic manufacturing is a plus, but recent graduates are encouraged to apply.