Demo

QC Chemist

ClinLab Staffing
Rockwell, NC Full Time
POSTED ON 4/15/2025
AVAILABLE BEFORE 5/14/2025

QC Chemist

Rockwell, NC

Responsibilities

  • Perform the receipt and logging of incoming pharmaceutical ingredients
  • Perform the sampling of incoming pharmaceutical ingredients for internal laboratory testing and shipment to external contract laboratories for testing
  • Perform internal laboratory testing (e.g., organoleptic tests, identification (FTIR), pH, viscosity, specific gravity, chemical assays (HPLC), etc.) on incoming pharmaceutical ingredients, in-process samples, finished products and stability samples
  • Calculate adjustments for in-process bulk product
  • Prepare and review internal laboratory testing and external contract testing laboratory reports for raw materials, in-process samples, finished products and stability samples
  • Prepare and review Certificates of Analysis
  • Notify manager immediately of non-conforming data or unexpected occurrences
  • Conducts laboratory investigations under the supervision of the laboratory supervisor
  • Prepare and/or review test procedures, SOPs and protocols as assigned.
  • Prepare and review IQ/OQ/PQ Protocols for production and laboratory equipment
  • Perform IQ/OQ/PQ testing on production and laboratory equipment
  • Complies with all regulatory/in-house requirements which may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP documentation


Requirements

  • Combination of advanced degree (such as Bachelors in Chemistry or related science) and 3 years of experience in high volume manufacturing preferred; extensive years of experience in lieu of advanced degree is acceptable
  • Previous experience within a cGMP compliant facility, Quality Control and USP Standards preferred
  • Ability to perform physical sampling/testing and instrumental chemical analysis in the chemical laboratory (e.g., chromatography, infra-red spectroscopy, titrations, etc.)
  • Excellent analytical and problem-solving skills
  • Excellent time management and organizational skills
  • Ability to work effectively in a fast-paced, rapidly changing environment
  • Excellent people skills, with demonstrated ability to communicate effectively across functional groups
  • Proficiency with Microsoft (MS) Office

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