Senior QA Specialist - Regulatory & CAPA Leader

Ultipro; Houston (TX); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Baylor Genetics is seeking a Senior QA Specialist to act as a quality SME across Laboratory Operations, Clinical, Regulatory, IT, and Product teams. You will identify systemic quality risks and translate data into actionable improvements to patient safety and regulatory compliance.

Responsibilities include leading CAPA, audits, and quality investigations; developing KPI dashboards and SOPs; mentoring staff and ensuring timely corrective actions in a fast-paced environment.

Qualifications

• Master’s or Bachelor’s degree with relevant quality experience in a clinical laboratory setting.
• Strong knowledge of CLIA, CAP, NYS requirements and regulatory frameworks.

Responsabilités

• Lead Quality Management System activities and ensure regulatory alignment.
• Manage quality events, investigations, CAPA, and root cause analyses.
• Lead audits and coordinate regulatory readiness efforts.
• Develop and monitor quality metrics, dashboards, and reports.
• Collaborate with cross-functional teams to resolve quality issues.
• Mentor staff and support training on quality processes.
• Support continuous improvement and risk-based thinking.

Connaissances

CLIA/CAP NYS

ISO15189/13485

SOPs writing

Data analysis

Audit experience

Quality investigations

Root cause analysis

Regulatory compliance

Quality data trends

Communication skills

Formation

Master’s degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or related field

Bachelor’s degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or related field

Outils

Smartsheet

SharePoint

MS Office Suite

Description du poste

Baylor Genetics is seeking a Senior QA Specialist to act as a quality SME across Laboratory Operations, Clinical, Regulatory, IT, and Product teams. You will identify systemic quality risks and translate data into actionable improvements to patient safety and regulatory compliance.

Responsibilities include leading CAPA, audits, and quality investigations; developing KPI dashboards and SOPs; mentoring staff and ensuring timely corrective actions in a fast-paced environment.