Job Listing Description

QC Analytical Data Reviewer

Description:
QC Analytical Data Reviewer
Direct Hire
Location: Saint Louis, MO (Fenton)
Shift: 8 – 5 (M-F)
Job Description:
Coordinate with other Quality Control chemists, R&D researchers and formulation specialists to ensure high quality standards are always met.

Summary:
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 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.

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.


 

 
Job Number: 2010114489
Job Location: Fenton, MO
Duration: 12 months
Input Date: 05/18/2020
Last Updated: 05/29/2020
Firm Name: PDS TECHNICAL SERVICES
Attention: Mike Simmerman
Address: 300 E JOHN CARPENTER FWY STE 700
City, State: IRVING, TX 75062
Phone: 214/647-9600
800 Phone: 800/270-4737
Fax Phone: 214/647-9630
Website: https://pdsjobs.force.com/candidates/job_detail?id=a1i1T000003OqdUQAS&URLSource=cjhunter

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