Analytical Chemist, QC Laboratory

POSTED: June 20, 2019
BUSINESS: PGC
POSITION TYPE: Full-time/Exempt
START DATE: Immediate Availability

Summary

PGC is a Center of Excellence for Pharmaceutical Development and Manufacturing, offering a full suite of solutions that supports its clients’ efforts in the innovation and commercialization of drug products.

PGC is currently looking for an analytical chemist to join the PGC team and participate in the Quality Control Laboratory. This individual will perform product testing on a wide range of drug product dosage forms and will be responsible for executing and maintaining key operations within the laboratory.

Roles and Responsibilities

  • Conducts both routine and complex chemical tests of raw materials following approved test methods
  • Performs testing of drug products by analytical techniques, which include HPLC, dissolution testing, UV-VIS spectroscopy, IR spectroscopy, TOC analysis, and Karl Fischer titration
  • Procures and manages the storage and disposition of reagents, standards, and test materials within the QC laboratory
  • Performs the routine maintenance, calibration, or qualification of analytical instrumentation
  • Adheres to laboratory and documentation practices that are consistent with Current Good Manufacturing Practices (“CGMP”)
  • Performs documentation review for peers
  • Delivers data reporting in a timely fashion and makes contributions to technical reports
  • Conducts laboratory investigations for out-of-specification and out-of-trend results
  • Assists management in prioritizing daily activities and continuously improving laboratory operations
  • Collaborates with other functional areas, as needed (e.g., Manufacturing, Product Development, Quality Assurance, Engineering/Facilities)
  • Contributes to protocol writing, protocol execution, or protocol reports (e.g., method validation or instrument qualification)

Qualifications

  • Bachelor's degree in chemistry, engineering, or other related science
  • Minimum of 2 years of experience working within a CGMP laboratory
  • Technical experience with some or all of the following analytical techniques: HPLC, dissolution, UV-VIS, IR, Karl Fischer titration, TOC, wet chemical methods
  • Experience with Empower chromatography and data analysis software is a plus
  • Strong organizational skills
  • Strong technical writing skills
  • Proficient in Microsoft Word, Excel, and Outlook
  • Ability to effectively interact in a multi-disciplined team environment
  • Favorable security (DEA/FBI/criminal) check and negative controlled substance test

Environmental/Hazardous Conditions:

Exposure to hazardous chemicals within a laboratory setting

Application Instructions:

Interested candidates please send your cover letter and resume to careers@gmpcenter.com

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