GMP QA Specialist – TrackWise & Quality Systems

Pharma Resource Group; Greendale (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

A pharmaceutical company based in Greendale, Indiana, is seeking a Quality Management Systems Specialist to support compliance and quality system activities. The ideal candidate will have over 2 years of experience in a GMP-regulated environment and strong organizational skills. Key responsibilities include oversight of quality systems, support for audits, and documentation management. This role offers an opportunity to impact quality assurance within a dynamic team.

Qualifications

• 2+ years of experience in a GMP-regulated environment.
• Experience with regulatory standards like 21 CFR 111, 211, or 11.
• Working knowledge of Quality Systems and Quality Assurance.

Responsibilities

• Support site-level quality systems and compliance activities.
• Participate in system upgrades and validation activities.
• Prepare documentation for internal and regulatory audits.

Skills

Experience in GMP-regulated environment

Knowledge of Quality Systems

Excellent communication skills

Strong organizational abilities

Tools

TrackWise

Microsoft Office Suite

Job description

A pharmaceutical company based in Greendale, Indiana, is seeking a Quality Management Systems Specialist to support compliance and quality system activities. The ideal candidate will have over 2 years of experience in a GMP-regulated environment and strong organizational skills. Key responsibilities include oversight of quality systems, support for audits, and documentation management. This role offers an opportunity to impact quality assurance within a dynamic team.