Quality Systems & Compliance Specialist (GMP/ISO)

PLZ Corp; Indianapolis (IN); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

Life insurance

Short-Term disability

401k match

Paid time off

Bonus programs

Job summary

PLZ Corp is seeking a Quality Specialist to support GMP-compliant quality systems, documentation, audits, and training in a regulated environment. The role may back up as a Quality Manager in certain situations.

The candidate will create and revise work instructions and forms, track audit responses, and set up training materials for updated SOPs and documents. The position emphasizes adherence to SOPs and safety practices across facilities.

Qualifications

• Minimum 2 years’ 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 compliance to GMP.
• Track and ensure that audit responses are on track.
• Set up training documents for new personnel and current employees for updated SOP, Forms and other documents as 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—know where the nearest exit is located, as well as nearest fire extinguisher, eyewash station, shower and exit is located.
• Other duties as assigned.

Skills

GMP experience

Documentation

Quality Systems

SOP management

Lean Six Sigma

Job description

PLZ Corp is seeking a Quality Specialist to support GMP-compliant quality systems, documentation, audits, and training in a regulated environment. The role may back up as a Quality Manager in certain situations.

The candidate will create and revise work instructions and forms, track audit responses, and set up training materials for updated SOPs and documents. The position emphasizes adherence to SOPs and safety practices across facilities.