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QC Analyst- (Quality- OTC Lab)

Englewood Lab, Inc

Totowa, new jersey


Job Details

Full-time


Full Job Description

  • Review daily instrument calibration and verifications; and review of logbooks
  • Review testing with other analysts and supervisor
  • Perform calibration and system suitability using approved Methods
  • Problem solve with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas. CAPA responsibility
  • Review NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records.
  • Assist with quality and environmental health and safety audits
  • Perform analytical testing using HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc.
  • Compliance to Data Integrity requirements
  • Assist with investigation of quality issues such Out of Specification (OOS), Out of Trends (OOT), etc.
  • Train on and support the chemical hygiene program for the laboratory
  • Execute testing methods, protocols and other work instructions
  • Assist in managing of chemical and consumable stocks
  • Perform calibrations and system suitability under supervision
  • Familiar with USP/NF Compendia, ASTM, ISO Stds
  • Familiarity with US FDA 21CFR Part 210 & 211 (Drug Product) and Cosmetic GMPs is mandatory

Requirements

  • Bachelor’s degree in Chemistry or related field
  • Strong knowledge in GMP, GLP, Root Cause Analysis & Corrective Action Planning Tools
  • Laboratory management experience preferred, with experience in Cosmetic or Pharmaceuticals desired
  • 1+ years Quality Control Analytical Lab experience with HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc
  • Good interpersonal and written communication
  • Flexible, ability to multitask and designate
  • Good organizational skills

Benefits

  • Medical, Dental, and Vision Insurance
  • Life Insurance
  • 401k match

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