Quality Systems Specialist (Bio/Pharmaceutical Industry 3452932

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

Quality Systems Specialist (Bio/Pharmaceutical Industry 3452932

Title: Quality Systems Specialist (Bio/Pharmaceutical Industry)

Location: Indiana, USA (Open to local candidates who are U.S. Citizens)

Position Type: Temp-to-Hire | 100% Onsite | By Contract with ProQuality Network

Schedule: Monday to Friday – 8-hour shift starting at 7:00 AM, 8:00 AM, or 9:00 AM

Period: Approximately 7 months

Open Positions: 1

Position Summary

ProQuality Network is seeking a Quality Systems Specialist to join our client’s Quality Assurance team in the state of Indiana, USA. This temp-to-hire opportunity is an integral part of maintaining and improving the site’s Quality Systems and overall regulatory compliance. The selected candidate will play a key role in supporting activities such as Change Controls, Deviations, Complaints, and CAPAs within TrackWise or similar quality management systems.

The ideal professional will possess a strong understanding of Good Manufacturing Practices (GMPs), experience in pharmaceutical or dietary supplement manufacturing, and the ability to manage multiple priorities within a compliance-driven environment.

Preferred Qualifications

• Experience with TrackWise, EDMS, or equivalent Quality Management Systems.
• Lean Six Sigma, Continuous Improvement, or Project Management training or certification.
• Experience supporting CAPA systems, audits, and regulatory documentation.

Key Responsibilities

Quality Systems Oversight

• Support site-level quality systems such as Change Controls, Deviations, Complaints, and CAPAs in compliance with internal procedures and cGMP regulations.
• Ensure documentation is accurate, thorough, and completed within defined timelines.
• Collaborate with cross-functional teams to support updates and continuous improvement initiatives.

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 continued compliance with regulatory standards.

Documentation and Audit Support

• Partner with Document Control and QA to ensure controlled documents remain current, compliant, and audit-ready.
• Support internal, client, and regulatory audits by preparing, organizing, and submitting requested documentation.
• Assist in batch record reviews, complaint initiation, and overall audit readiness activities.

Required Qualifications

• Bachelor’s Degree in a scientific or related discipline (e.g., Biology, Chemistry, Microbiology, or Quality Management).
• Minimum 2 years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement industry preferred).
• Working knowledge of 21 CFR 111, 21 CFR 211, and/or 21 CFR 11.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Strong written and verbal communication skills.
• Excellent organizational and time management abilities.
• Proven ability to work collaboratively across departments and functions.

Join Our Team

If you are a quality-driven professional seeking to advance your career in a fast-paced, FDA-regulated environment, Join ProQuality Network and contribute to our client’s mission of maintaining compliance, quality excellence, and continuous improvement.