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Quality Assurance Lead
Fortrea. Serve as a quality partner to operational teams by providing guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) and the Corrective and Preventive Actions (CAPA) process, with a strong understanding of GCP and GxP requirements. Capable of analyzing quality metrics and trends to drive continuous improvement and ensure compliance.
Highest-signal resume keywords
Quality Management System (QMS)Corrective and Preventive Actions (CAPA)GxP ExperienceGCP KnowledgeQuality Issue Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Issue ManagementQuality Risk IdentificationTrend AnalysisContinuous ImprovementRegulatory Compliance
Soft Skills
Effective CommunicationCollaborationProblem Solving
Tools & Technologies
Quality Management SoftwareData Analysis Tools
Industry Keywords
GxPGCPLife SciencesQuality Oversight
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Serve as a quality partner to operational teams by providing guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities
- Partner with internal stakeholders to facilitate the progression and resolution of quality issues within the Quality Management System (QMS)
- Monitor and drive timely progression of quality issues while identifying and escalating risks that may impact compliance, quality, or client commitments
- Collaborate with functional teams to develop, implement, and monitor Corrective and Preventive Actions (CAPAs)
- Maintain working knowledge of quality systems, processes, and regulatory requirements to support quality issue management
- Partner with Quality Lead Managers and senior quality leadership on quality issue progression, escalation activities, and client communications
- Analyze quality metrics and trends to identify systemic quality concerns, emerging risks, and opportunities for continuous improvement
- Support preparation of quality summaries, trend analyses, and quality-related communications for internal stakeholders and clients
- Contribute to process improvement initiatives strengthening compliance, quality oversight, and operational effectiveness
- Perform other duties as assigned
- Occasionally drive to site locations and travel domestically and internationally
Requirements
What you’ll need- 5 years of experience in a regulatory environment, including experience in GxP roles
- Strong understanding of QMS and the CAPA process
- Knowledge of GCP and GxP requirements
- Ability to convey key details of quality issues internally
- Ability to communicate quality issue summaries to clients, where applicable
- A bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience
- Relevant and equivalent experience may be considered in lieu of educational requirements
- Candidates must be authorized to work in the United States without sponsorship
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Regular and consistent attendance
- Varied hours may be required
- Frequently stationary for 6-8 hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Benefits
Comp & perks- Medical
- Dental
- Vision
- Life insurance
- Short-term disability (STD)
- Long-term disability (LTD)
- 401(K)
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable