Quality Specialist

PLZ, Corp•Indianapolis, IN

About The Position

The Quality Specialist supports quality systems, documentation, audits, and training in a GMP environment, following ISO and FDA GMP regulations as well as SOPs, GMP, GLP, and GDP. The role also serves as a backup for the Quality Manager. PLZ produces aerosol and liquid products across manufacturing facilities and emphasizes product stewardship, innovation, ethical standards, sustainable operations, health and safety, and employee development. The position includes following company safety policies and using personal protective equipment.

Requirements

  • At least 2 years of experience working in a GMP environment.
  • Experience with documentation, quality systems, and SOP management.
  • Experience in Lean Six Sigma.

Responsibilities

  • Create and revise work instructions, forms, one-point lessons, and other controlled documents to support GMP compliance.
  • Track audit responses and ensure they remain on schedule.
  • Set up training documents for new personnel and current employees when SOPs, forms, or other documents are updated.
  • Participate in internal and external audits.
  • Assist with root cause analysis.
  • Assist with implementation of 5S.
  • Wear personal protective equipment.
  • Follow company safety policies, rules, and regulations.
  • Participate in practice evacuation drills and know the locations of the nearest exit, fire extinguisher, eyewash station, and shower.
  • Perform other duties as assigned.
  • Back up the Quality Manager.

Benefits

  • Medical, dental, and vision benefits.
  • Company-paid life insurance and short-term disability.
  • Voluntary additional life, disability, and hospital/accident insurance.
  • 401(k) with company-provided match.
  • Paid time off.
  • Bonus incentive programs, subject to program rules and individual and organizational performance.
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