Quality Specialist

PLZ Corp • Indianapolis, IN

26d

About The Position

The Quality Specialist supports quality systems, documentation, audits, and training in a GMP environment, adhering to ISO and FDA GMP regulations and following SOPs, GMP, GLP, and GDP. The role also provides backup support for the Quality Manager.

Requirements

• At least 2 years of experience working in a GMP environment.
• Experience in 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.
• Prepare training documents for new personnel and current employees when SOPs, forms, or other documents are updated or required.
• 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.
• Provide backup support for the Quality Manager.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed