Operational Quality Specialist
Location: Madison, WI (On-Site)
Category: Clinical
Job ID: 254008
Employment Type: Full-Time
Work Hours: Mon–Fri, 8:00 AM – 4:00 PM (flexibility to start earlier or stay later depending on clinical trial needs)
Job Overview
Fortrea is seeking an Operational Quality Specialist to ensure the highest quality standards in Early Phase clinical trials. This role involves overseeing operational quality, interpreting regulatory requirements, leading process improvements, and providing training and mentoring to study staff. The specialist collaborates cross-functionally, represents Fortrea during audits and inspections, and drives continuous operational excellence.
Key Responsibilities
1. Quality Assurance & Compliance
Interpret GCPs, GLPs, cGMPs, and other regulatory documents to support auditing and process improvement.
Ensure all work complies with study protocols, SOPs, and international GCP standards.
Lead site-level Failure Mode and Effects Analysis (FMEA) activities.
Draft and manage Corrective and Preventive Action (CAPA) reports.
Support client quality reviews and address ad-hoc quality findings.
Oversee assigned CAPAs to ensure timely closure and proper documentation.
2. Process Improvement & Operational Excellence
Take ownership of assigned quality review components for clinical projects.
Compile and analyze quality metrics to identify trends and areas for improvement.
Lead process review initiatives to standardize and improve operational workflows.
Facilitate quality discussion forums within Clinical Research Units (CRUs) to identify errors, share best practices, and implement improvements.
Analyze operational data and recommend strategies for efficiency and excellence.
3. Cross-Functional Collaboration & Leadership
Collaborate with Clinical Pharmacology Services (CPS), QA teams, and project managers to support audits and inspections.
Provide leadership, training, coaching, and mentoring to study staff.
Promote consistent, efficient, and high-quality processes to meet project timelines and deliverables.
4. Additional Duties
Conduct QC checks, track metrics, perform data reconciliation, and other operational support activities as needed.
Perform other duties as assigned.
Qualifications
Required:
Minimum 4 years CRO industry experience, preferably in Phase I clinical trials.
Strong knowledge of GCP, GMP, and applicable FDA/EU regulatory guidelines.
Experience in Quality Assurance, including CAPA management and generating quality metrics.
Proficiency in Microsoft Office applications.
Excellent written and verbal communication skills.
Ability to interpret study protocols and operational SOPs.
Preferred:
Familiarity with operational process improvement methodologies.
Strong analytical skills for trend analysis and quality data review.
Work Environment
Fast-paced environment where strict adherence to study protocol is critical.
Constantly changing priorities requiring adaptability.
Team-oriented, collaborative environment.
Technology-based with electronic data collection systems.
Benefits
Comprehensive benefits for employees working ≥20 hours/week:
Medical, Dental, Vision, Life, STD/LTD insurance (multiple carriers)
401(K) plan
Paid Time Off (PTO)
Employee recognition awards
Multiple Employee Resource Groups (ERGs)
EEO & Accommodations
Learn more about Fortrea’s Equal Employment Opportunity and accommodations here.
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