GMP Quality Systems Specialist — Audits & Training

PLZ Corp; Indianapolis (IN); On-site; USD 55,000 - 76,000; Full time

Benefits offered by this job

Company paid Life and Short-Term disb

Voluntary benefits including life, and

401k & company provided match

Paid Time Off

Bonus incentive programs

Job summary

PLZ Corp in Indianapolis, IN is seeking a Quality Specialist to support GMP quality systems, documentation, audits and training in a regulated environment. The role covers SOP management, document control, and ensuring compliance with ISO, FDA GMP, GDP and related SOPs.

You will participate in audits, assist with root cause analysis, and help implement 5S while adhering to safety guidelines and company policies. This position emphasizes teamwork and continual improvement.

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

Quality Systems

SOP management

Lean Six Sigma

Job description

PLZ Corp in Indianapolis, IN is seeking a Quality Specialist to support GMP quality systems, documentation, audits and training in a regulated environment. The role covers SOP management, document control, and ensuring compliance with ISO, FDA GMP, GDP and related SOPs.

You will participate in audits, assist with root cause analysis, and help implement 5S while adhering to safety guidelines and company policies. This position emphasizes teamwork and continual improvement.