Quality Systems Specialist; Bio/Pharmaceutical Industry
Listed on 2026-10-07
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
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 Pro Quality 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
Pro Quality 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 Track Wise 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 Track Wise
, 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 Track Wise
, 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 Pro Quality Network and contribute to our client’s mission of maintaining compliance, quality excellence, and continuous improvement.
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