JOB SUMMARY The Senior QA Specialist serves as a Quality subject matter expert and trusted partner to Laboratory Operations, Clinical, Regulatory, Technology, Product, Customer Experience, and other cross-functional teams. The role is expected to identify systemic quality risks, influence stakeholders, and translate quality data into actionable improvements that strengthen patient safety, regulatory compliance, operational performance, and customer experience. This role ensures alignment with company values and mission while maintaining compliance with relevant regulations and standards.
KEY RESPONSIBILITIESQuality Management System• Independently execute and oversee assigned elements of the Quality Management System.
• Interpret and apply applicable quality and regulatory requirements, including CLIA, CAP, FDA, NYS and other applicable requirements.
• Identify gaps in quality processes, procedures, controls, and documentation and recommend appropriate improvements.
• Support development, revision, implementation, and effectiveness monitoring of SOPs, policies, forms, and quality processes.
• Promote a proactive, risk-based approach to quality management.
Quality Events, Investigations & CAPA- Lead complex and cross-functional quality event investigations, including nonconformances, deviations, errors, complaints, and other quality events.
- Perform and facilitate effective root cause analysis using appropriate tools such as 5 Whys, Fishbone, process mapping, and data analysis.
- Distinguish root cause from contributing factors and symptoms and ensure investigations are supported by objective evidence.
- Develop and manage CAPAs that address systemic causes and prevent recurrence.
- Evaluate CAPA effectiveness and identify additional actions when corrective actions are ineffective.
- Monitor quality event trends and identify recurring or systemic issues requiring escalation.
- Ensure quality events and CAPAs are completed within established timelines and meet quality standards.
Audits & Regulatory Readiness- Lead or participate in internal, supplier, customer, and regulatory audits.
- Develop audit plans, review objective evidence, conduct interviews, document findings, and support audit reporting.
- Coordinate responses to audit findings and monitor corrective actions through closure.
- Support preparation for regulatory and accreditation inspections, including CAP, CLIA, FDA, NYS and other applicable agencies or accreditation bodies.
- Identify recurring audit observations and recommend systemic improvements to prevent recurrence.
Quality Metrics & Data Analysis- Develop, analyze, and monitor quality metrics and key performance indicators.
- Identify trends, patterns, outliers, and emerging risks through quantitative and qualitative analysis.
- Translate quality data into actionable recommendations for operational and leadership teams.
- Support development of leading and lagging quality indicators.
- Prepare clear reports, dashboards, and presentations for Quality and cross-functional leadership.
- Use data to evaluate effectiveness of corrective actions and improvement initiatives.
Cross-Functional Collaboration- Partner effectively with Laboratory Operations, Clinical, Medical, Regulatory, IT, Customer Experience, and other functions to resolve quality issues.
- Facilitate cross-functional investigations and problem-solving sessions.
- Influence stakeholders and drive accountability without relying on formal authority.
- Communicate quality risks and recommendations clearly to technical and non-technical audiences.
- Represent Quality on cross-functional projects and initiatives.
Training & Knowledge Sharing- Mentor and provide technical guidance to Quality Specialists and other team members.
- Support development and delivery of quality-related training.
- Promote consistent application of quality processes and investigation methodologies.
- Share lessons learned and best practices across the organization.
Other Responsibilities• Participate in Quality Management meetings and strategic initiatives.
• Support development and implementation of quality policies, programs, and improvement initiatives.
• Maintain current knowledge of applicable laboratory, regulatory, accreditation, and quality requirements.
• Adhere to the Code of Conduct as outlined in the Baylor Genetics Compliance Program.
• Perform other job-related duties as assigned.
QUALIFICATIONSRequired• Master's degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or a related field with 3 years of quality experience in a clinical laboratory setting or equivalent combination of experience.
Or
• Bachelor's degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or a related field with 6 years of quality experience in a clinical laboratory setting or equivalent combination of experience.
COMPETENCIES• In-depth knowledge of CLIA, CAP, NYS standards, and regulations.
• Experience with ISO15189 and 13485, preferred.
• Fundamental understanding of clinical and/or laboratory testing.
• Experience in writing, reviewing, and editing SOPs and other document types.
• Ability to work in a collaborative team environment with a customer-focused approach.
• Proficiency in Microsoft Office (MS Word, Excel, Outlook, PowerPoint), Smartsheet, and SharePoint.
• Ability to work independently, organized, self-motivated, and results-oriented.
• Demonstrated experience with quality investigations, root cause analysis, CAPA, and quality event management.
• Experience with internal or external audits and regulatory/accreditation requirements.
• Experience analyzing quality data and identifying trends.
• Strong understanding of quality management principles and risk-based thinking.
• Demonstrated ability to independently manage multiple priorities and complex projects.
• Strong written, verbal, analytical, and organizational skills.
PHYSICAL DEMANDS AND WORK ENVIRONMENT- Frequently required to sit.
- Frequently required to stand.
- Frequently required to utilize hand and finger dexterity.
- Frequently required to talk or hear.
- Frequently required to utilize visual acuity to operate equipment, read technical information, and/or use a keyboard.
- Occasionally exposed to bloodborne and airborne pathogens or infectious materials.
