Instrumentation Chemist - Extractable & Leachable
SGS North America Inc.

Fairfield, New Jersey


Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

Primary Responsibilities
Performs sample preparation, GC-MS/FID and/or LC-MS/PDA and/or ICP-MS/OES analysis on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices. Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs.
Reporting To:

  • Chemistry Supervisor-E&L, Life Science Services, Fairfield
Specific Responsibilities
Operate and maintain laboratory equipment and instrumentation required for cGMP analysis of samples
prepare chemical solutions following standard operating procedures and appropriate testing methods
operate and maintain Gas Chromatograph with Mass Spectrometer (GC-MS) and/or High-Pressure Liquid Chromatograph with Mass Spectrometer (LC-MS)
maintain an inventory of laboratory chemicals and disposable equipment necessary for the daily functioning of the laboratory
write and review protocols and reports for Extractables and Leachables (E&L) studies; perform testing in accordance with specified methods; and document activities in accordance with cGMP.

Qualifications


Must have a Bachelor's degree in degree in in Chemistry, Food Safety and Technology, or related field
must have 1 year of experience with GC-MS or LC-MS techniques, in terms of instrument operation, maintenance, and troubleshooting, and data interpretation for small molecule applications;
1 year of experience with operational software of analytical instruments and with Microsoft Office
1 year of experience with experimental design and documentation
1 year of experience with chemical solution and sample preparation, chemical weighing following protocols.


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