Quality Assurance Specialist

Corner Stone Professional Placement is seeking a Quality Assurance Specialist to support a regulated healthcare organization in the Fort Worth, TX area. This is an on‑site contract opportunity for an experienced QA professional with a strong background in quality systems, investigations, and distribution‑related compliance.

This position will serve as the primary Track Wise SME
, leading quality events from initiation through closure, including deviations, investigations, complaints, and CAPAs. The ideal candidate will have extensive experience in a cGMP‑regulated environment and a proven ability to ensure compliant documentation, root cause analysis, and corrective action effectiveness.

The Quality Assurance Specialist will also support distribution and finished goods quality activities such as product release, visual inspection processes, and temperature monitoring programs. This role will interact with external partners, including third‑party manufacturers and logistics providers, to support complaint handling and product quality oversight.

• Serve as the primary Track Wise Subject Matter Expert (SME)
• Lead end‑to‑end quality investigations, deviations, complaints, and CAPAs
• Ensure documentation is complete, accurate, and compliant with cGMP/GxP requirements
• Perform root cause analysis and drive corrective/preventive action development
• Support distribution and finished product release activities, including disposition decisions
• Conduct visual inspections and support temperature monitoring/excursion programs
• Oversee complaint investigations involving external manufacturing and logistics partners
• Support new product introductions and quality system readiness activities
• Review labeling and artwork for compliance with applicable regulations and internal standards
• Participate in audits and regulatory inspections as needed
• Support continuous improvement initiatives within the quality organization

• 5+ years of Quality Assurance experience in a regulated environment (pharma, biotech, medical device, etc.)
• Strong working knowledge of cGMP and GxP regulations
• Experience supporting QA compliance within distribution, warehousing, and supply chain operations
• Proven ability to manage investigations and CAPAs with strong attention to detail

• Lean or Six Sigma Yellow Belt certification
• Schedule: Monday–Friday | 8:00 AM – 5:00 PM
• Pay Rate: $42–$50/hour + benefits
• Location: On‑site | Fort Worth, TX

Please send resumes to k for immediate consideration!