What are the responsibilities and job description for the QC Inspector & GMP Leader - Level II (Quality) position at Englewood Lab?
Title: QC Inspector & GMP Leader- Level II
Reports to: QC Supervisor or Designee
Department: Quality
Responsibilities:
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
- 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)
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match