QC Analyst- Night Shift only

6/27/22

Bethlehem, PA

1738

Perform analytical testing of In-Process, Bulk, Raw Material, Stability and Finished Product material to provide information about the quality of the material and decisions into the next steps in the manufacturing process.
  • Perform routine sample preparation and analysis with experience in at least 1 of the following instrumentation: (GC, UV-VIS, FTIR, AA, ICP/MS, KF) for in-process, finished, stability, raw materials and various samples created during R&D and process development activities
  • Sampling, inspection, and testing of raw materials upon receipt
  • Sampling, inspection, and testing of packaging components upon receipt
  • Testing in-process material as directed in the applicable in-process specifications
  • Testing bulk drug substances as directed in the applicable in-process specifications
  • Testing finished drug product as directed in the applicable specifications
  • Perform quality laboratory investigations in response to out-of-specification, apparent failure or questionable results
  • Proper GMP documentation of all applicable activity
  • Calibration of instruments when necessary
  • Solution and calibration standards preparation
  • Maintain lab notebooks
  • Gas cylinder change-outs
  • Help maintain the stability program, including sample acquisition, storage, testing examination, and record-keeping
  • Review production in-process records
  • Follow SOPs and maintain good documentation during work: data management and maintenance to ensure compliance for audit preparation
  • Write analysis reports
  • Perform peer review of other analysts' work
  • Design and execute lab experiments with input from Technical chemist and Quality Control Supervisor/Manager
  • Experimentally maintain and improve analytical methods, including in-process sample and drug product release
  • Keeps supplies ready by inventorying stock; help placing orders; verifying receipt
  • Works 12 hour shift (nights or days) depending on shift you are hired for
  • Work in a strict GMP environment

B.S. in Chemistry or closely related degree or Associates Degree in Science with lab experience.
0 to 3 years of experience in a GMP laboratory setting
Familiar with GMP/GLP and FDA requirements a plus
Strong documentation skills
Able to work independently
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