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Chemical Quality Control Specialist

2 months ago

Vandalia, Ohio, United States Adare Pharma Solutions Full time
Job Summary

The Quality Assurance Chemist is a critical member of our Quality Control Team, responsible for performing physical and chemical testing of intermediate and finished products according to written procedures.

Key Responsibilities
  • Demonstrate knowledge of various test methods and instrument analysis techniques, including sample preparation, titration, analytical balances, extractions, dilutions, chromatography, pH, and dissolution.
  • Prepare various standards, mobile phases, and buffers as needed for various test methods.
  • Perform physical and chemical testing of raw materials, intermediate, and finished products as described in the documented procedures to support product release and process validation protocols.
  • Suggest method modifications as required.
  • Understand and apply USP methods.
  • Perform testing requiring rotating bottle, titrations, dissolution baths, and other basic laboratory equipment.
  • Perform test methods that utilize instruments such as UV, FTIR, GC, and HPLC.
  • Demonstrate the ability to operate the instrument software application, set up basic sequences, and report data.
  • As required, perform swabbing and analysis of equipment cleaned by manufacturing with minimal supervision.
  • Perform assigned calibrations for equipment in the laboratory as required and maintain the required documentation for compliance.
  • Recognize and report Out of Specification results, Out of Trend results, and deviations to Supervisor.
  • Assist with investigation steps as required for LIR/OOS Investigations.
  • Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures.
  • Peer review and/or audit others' work as required for verification of GMP compliance.
Requirements
  • Bachelor's Degree in Chemistry or related field.
  • 1+ years of experience working in a Quality Control or Research and Development Laboratory, preferably in the pharmaceutical industry.
  • Excellent interpersonal, written, and oral communication skills.
  • Working knowledge of current Good Manufacturing Practices (GMPs).
  • Proficient in Microsoft Excel, Word, and Microsoft Access.
  • Basic knowledge of technical writing coupled with good oral communication skills.
Physical Requirements
  • Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
  • Occasionally required to climb ladders and/or steps to reach equipment.
  • Requires reading precision measuring equipment, machine dials, gauges, and thermometers; must be able to observe fine details utilizing a microscope.
  • Must have sense of smell to detect odors of unacceptable compounds and/or mixtures.
  • Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.