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QC Inspector & GMP Leader - Level II (Quality)

Englewood Lab
Totowa, NJ Full Time
POSTED ON 1/12/2025
AVAILABLE BEFORE 5/10/2025
Title: QC Inspector & GMP Leader- Level II

Reports to: QC Supervisor or Designee

Department: Quality

Responsibilities:

  • Performs in-process inspection and finished product audit to assure conformance to specs, standards and SOPs
  • Perform periodic GMP Walk and Inspection of Production areas with associated follow-ups
  • Performs in-process and finished product documentation review to assure process and product integrity per SOPs
  • Co-ordinates specific customer samples and associated correspondence and quality reports
  • Co-ordinate test and retain samples as required per SOPs
  • Supports the QC Lead and QC Manager with special duties and assignments related to line inspections, material disposition
  • Using EWL SOPs and approved F/As, performs periodic inspection of in-process activities on assembly lines (filling and packaging operations); prepares documentation of same for review by QC Group Leader or immediate supervisor
  • Perform periodic GMP walk and inspection of productions lines and areas, with documentation and follow-ups. Maintains leadership of GMPs on the floors
  • Reviews completed documentation on Production and Assembly floors including Worksheets, Fill Cards, and any other associated materials for correctness and completeness. Also, documents such review on Audit sheet
  • Reviews QC/packaging documents and pull any samples as required per AQL, from Assembly lines
  • Signs off on Assembly Line Clearance sheets and review documentation during Lot change
  • Performs Code verification on Assembly Line sheets
  • Performs finished good audits in the warehouse
  • Maintains "General Appearance Samples", "First Article Samples" and Line
  • Standards for Assembly Line operations


Requirements

  • High School diploma or GED or equivalent
  • One to three years of experience in cosmetic, device, food or pharma is a plus
  • Good math skills
  • Ability to read and interpret internal and external sampling plans and effectively report results
  • Effective English Language communication skills (speaking and writing)


Benefits

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

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