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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing quality processes and projects, including CAPA management and root cause analysis methodologies such as FMEA and Fishbone Analysis. Proficient in maintaining compliance with GxP regulations and conducting investigations to support continuous improvement initiatives.
Highest-signal resume keywords
Quality ManagementRoot Cause AnalysisCAPA ManagementGxP RegulationsContinuous Improvement
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 OperationsInvestigationsCorrective Action PlansPreventive Action PlansData AnalysisProblem-Solving Methodologies5 WhysFishbone AnalysisFMEAQuality Systems
Soft Skills
Critical ThinkingCommunicationCollaborationDecision-MakingDocumentation
Industry Keywords
SOPsComplianceQuality RecordsInternal AuditsExternal Audits
About the role
Key responsibilities & impact- Manage complex quality processes and advanced quality management projects across manufacturing and distribution
- Make independent decisions within assigned project areas
- Monitor product quality and resolve non-conformances
- Lead and document investigations into deviations, non-conformances, and quality events
- Conduct root cause analyses using 5 Whys, Fishbone Analysis, FMEA, and other tools
- Develop, implement, and monitor corrective and preventive action (CAPA) plans
- Collaborate with Manufacturing, Quality, Engineering, and Regulatory Affairs teams
- Communicate investigation status, findings, risks, and scope updates to leadership and stakeholders
- Prepare investigation reports, CAPA summaries, and documentation for management reviews and regulatory inspections
- Maintain quality records in compliance with GxP regulations and internal procedures
- Ensure adherence to SOPs, training requirements, and applicable regulations
- Support internal and external audits
- Analyze quality data and trends to identify continuous improvement opportunities
- Conduct independent research and apply critical thinking to quality initiatives
- Contribute to organizational quality and compliance objectives
Requirements
What you’ll need- Bachelor’s Degree or equivalent years of directly related experience
- Alternatively, high school plus 8 years of experience
- Alternatively, associate degree plus 4 years of experience
- Fluent reading, writing, understanding, and communication in English
- Ability to work Monday–Friday, 8:00 AM–5:00 PM CST
- 0% travel requirement
- Must work onsite in Houston, Texas
- Sponsorship and relocation are not available
- Ability to perform quality operations, investigations, CAPA management, compliance, and continuous improvement activities
- Knowledge of GxP regulations, SOPs, quality systems, root cause analysis, FMEA, and related problem-solving methodologies
Benefits
Comp & perks- Health insurance
- Life insurance
- Retirement benefits
- Flexible time off for exempt associates
- PTO for hourly associates
- Focused growth and development opportunities
- Reasonable accommodation for individuals with disabilities