QC Analytical Data Reviewer

5/8/20

St. Louis, MO

981

FullTimeRegular

Title: QC Analytical Data Reviewer

Function: Coordinate with other Quality Control chemists, R&D researchers and formulation specialists to ensure high quality standards are always met.

Primary Responsibilities and Essential Functions of the Position:

  • Follow cGMP, cGLP, and OSHA guidelines with regard to work practices and safety.
  • Review data, reports and Standard Operating Procedures (initial creation and revisions), as required.
  • Write, and revise Standard Operating Procedures (SOPs), as required.
  • Review and revise laboratory systems.
  • Lead laboratory investigations.
  • May be required to Analyze raw, intermediate, final product and stability samples per compendial guidelines
  • May be required to Qualify, calibrate, and maintain chemical laboratory equipment as well as general laboratory maintenance.
  • Other duties as assigned.

Skills and Abilities Required:

  • Experience in USP analysis and review with HPLC and/or GC methods.
  • Experience preparing cGMP and other laboratory documents.
  • Proficient in chromatography software for analysis and review purposes.
  • Proficient in technical writing.
  • Proficient in leading and writing laboratory investigations.
  • Experience with cGMP and FDA regulations.
  • Excellent organizational skills.
  • Effective communication both verbally and written.
  • Proficient in Microsoft Word, Excel, and PowerPoint.

Minimum Education and Experience Required:

  • A Bachelor’s degree in Chemistry with a minimum of five (5) years of laboratory experience, preferably in the pharmaceutical industry; Master’s degree in Chemistry with a minimum of three (3) years laboratory experience, preferably in the pharmaceutical industry; Ph.D. with a minimum of two (2) years laboratory experience preferably in a pharmaceutical industry.

Preferred Education and Experience:

  • 5-10 years of experience in a Pharmaceutical GMP facility.
  • 5-10 years of experience troubleshooting HPLC and GC.
  • Proficient in Chromeleon and Chemstation software.
  • 5-10 years of experience with ICH, DEA, Head Space, and IC regulation knowledge.
  • General knowledge of microbiology, for review purposes.
  • USP, EP, BP and JP methods of analysis, all or some.
  • Experience in Nasal Spray analysis and review.

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