QC Analytical Data Reviewer
St. Louis, MO
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.