Quality Assurance Specialist (GMP / TrackWise Experience Preferred)

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

Position Summary

Client is seeking a temporary Quality Management Systems Specialist to join our dynamic Quality Assurance team at our Greendale, Indiana site. This role is critical to the integrity and continuous improvement of our site’s Quality Systems and will be responsible for supporting key compliance and quality system activities such as entry of Change Controls, Deviations, Complaints, and CAPAs into TrackWise. The ideal candidate will bring an understanding of GMP principles, experience in pharmaceutical or dietary supplement manufacturing, and basic user knowledge of electronic quality systems (i.e. TrackWise or similar).

Responsibilities

• Quality Systems Oversight
  • Support site-level quality systems such as: Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
  • Ensure timely and thorough completion of assigned documentation tasks.
  • Support cross-functional teams with quality system updates.
• Computerized System Compliance
  • Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.
  • Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.
• Documentation & Audit Support
  • Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.
  • Support internal, client, and regulatory audits by preparing documentation as assigned.
  • Assist in batch record review/filing, complaint investigation initiation, and audit readiness activities as needed.

Essential Skills, Experience, Qualifications

Required:

• 2+ years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred).
• Experience with 21 CFR 111, 21 CFR 211, or 21 CFR 11.
• Working knowledge of Quality Systems and Quality Assurance
• Experience with Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Strong organizational and time management abilities.

Preferred:

• Experience with TrackWise and/or EDMS or equivalent
• Lean Six Sigma or similar continuous improvement training
• Project Management