Quality Control Chemist

Reflik
13301 South Main Street
Los Angeles, CA 90061
United States

Category
Industry
Pharmaceutical
Experience Required
Yes
Degree Required
Yes
Employment Type
Employee
Work Schedule
Full-Time
Travel
No Travel

Job Description

 

Senior Quality Control Chemist


SUMMARY: 

The Senior QC Chemist will be involved in activities that include performing analysis in a GMP/GLP environment for release testing, supporting manufacturing functions (engineering, validation, etc), stability studied and method validation and transfer. The Senior QC Chemist will also be involved into working with Validation, R&D, Operations, Supply Chain and Contract Laboratories.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Perform testing using analytical equipment (HPLC, GC, IR, UV, TOC etc.) as well as using traditional wet chemistry methods (i.e. titration, TLC, etc)
  • Be proficient or serve as in-house Subject Matter Expert on Instrument operation, including but not limited to HPLC, GC, FTIR, etc..
  • Participate in Tech Transfer and method development activities with R&D personnel.
  • Perform analytical method transfer, and validation as directed from provided protocols.
  • Process and interpret chromatographic data independently & communicate significance of results to management, while maintaining Data Integrity standards.
  • Enter experimental information into lab notebooks and process analytical data accordingly.
  • Review analytical data for accuracy and release/reject results.
  • Review and edit of protocols, reports, or other technical documents, and present project data to group, as needed.
Job Requirements
Must have a Bachelor’s Degree in Chemistry or related science.
5 + years’ experience in a regulated industry (i.e. pharmaceutical, dietary supplement, biotech, etc); or equivalent combination of education, training and/or experience.
2 to 3 years of experience with USP/AOAC is required.
Hands-on experience with chromatography equipment is required.
Experience with EP, BP, ACS, and ICH guidelines is preferred.
Experience with Waters HPLC equipment and Empower 3 Chromatography Software is preferred.
Experience with preventive maintenance and calibration of instruments is preferred.
Experience working in a regulated (i.e. FDA, NPA, etc) GMP environment is required.
Experience with analytical method verification, development, validation or transfer, is required.
Experience in operating, maintaining, and troubleshooting instruments is preferred.
Experience using analytical instrumentation including analytical balances, TOC, spectrophotometers, etc. is required.
Experience in maintaining data integrity is required.
Experience reviewing audit trails a strong plus.
Employer
Geoscience Jobs

Somerset NJ
United States
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