Quality Systems Specialist – GMP/TrackWise, Onsite Indiana

ProQuality Network; Northern (KY); Hybride; USD 60 000 - 90 000; Plein temps

Résumé du poste

ProQuality Network seeks a Quality Systems Specialist to join the client’s QA team in Indiana. This temp-to-hire, 100% onsite role focuses on maintaining regulatory compliance and quality systems, including CAPAs, deviations, and change controls.

The ideal candidate will have GMP experience in pharma or dietary supplement manufacturing, knowledge of TrackWise/EDMS, and a proven ability to manage multiple priorities in a regulated environment.

Qualifications

• Bachelor’s Degree in a scientific or related discipline.
• Minimum 2 years of experience in a GMP-regulated environment.
• Working knowledge of 21 CFR 111, 211, and/or 11.
• Proficient in Microsoft Office Suite.

Responsabilités

• Quality Systems Oversight: support Change Controls, Deviations, Complaints, and CAPAs in compliance with internal procedures and cGMP.
• Ensure documentation is accurate, thorough, and on time.
• Collaborate with cross-functional teams to support updates and continuous improvement initiatives.

Connaissances

GMP knowledge

Written & verbal communication

Organizational & time management

Cross-functional collaboration

Formation

Bachelor's Degree in science or related field

Outils

TrackWise

EDMS

Quality Management Systems

Microsoft Office

Description du poste

ProQuality Network seeks a Quality Systems Specialist to join the client’s QA team in Indiana. This temp-to-hire, 100% onsite role focuses on maintaining regulatory compliance and quality systems, including CAPAs, deviations, and change controls.

The ideal candidate will have GMP experience in pharma or dietary supplement manufacturing, knowledge of TrackWise/EDMS, and a proven ability to manage multiple priorities in a regulated environment.