QC Inspector & GMP Leader - Level II (Quality)
Englewood Lab - totowa, NJ
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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
Created: 2024-11-16