QC Inspector & GMP Leader - Level II (Quality)

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