Senior Quality Assurance Specialist

🔥 14 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Baylor Genetics

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Baylor Genetics is a clinical genomics and precision diagnostics laboratory affiliated with Baylor College of Medicine that provides comprehensive genetic testing and interpretation services. The company offers whole genome and whole exome sequencing, chromosomal microarray analysis, mitochondrial testing, pharmacogenomics, and specialized assays, along with genetic counseling, provider support, and insurance/payment resources. Baylor Genetics supports healthcare providers, researchers, and families with AI-enhanced interpretation, multimodal data integration, and end-to-end clinical and laboratory services.

📋 Description

• Serve as a Quality subject matter expert and trusted partner to Laboratory Operations, Clinical, Regulatory, Technology, Product, Customer Experience, and other cross-functional teams • 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 requirements • Identify gaps in quality processes, procedures, controls, and documentation and recommend improvements • Support development, revision, implementation, and effectiveness monitoring of SOPs, policies, forms, and quality processes • Lead complex and cross-functional quality event investigations, including nonconformances, deviations, errors, complaints, and other quality events • Perform and facilitate root cause analysis using 5 Whys, Fishbone, process mapping, and data analysis • Develop and manage CAPAs, evaluate CAPA effectiveness, and identify additional actions when needed • Monitor quality event trends and recurring or systemic issues requiring escalation • 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 CAP, CLIA, FDA, NYS, and other regulatory or accreditation inspections • 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 • Prepare reports, dashboards, and presentations for Quality and cross-functional leadership • Partner 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 formal authority • Represent Quality on cross-functional projects and initiatives • Mentor and provide technical guidance to Quality Specialists and other team members • Support development and delivery of quality-related training • Participate in Quality Management meetings and strategic initiatives • Support development and implementation of quality policies, programs, and improvement initiatives • Adhere to the Code of Conduct in the Baylor Genetics Compliance Program • Perform other job-related duties as assigned

🎯 Requirements

• 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 • 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 • 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 writing, reviewing, and editing SOPs and other document types • Proficiency in Microsoft Office (MS Word, Excel, Outlook, PowerPoint), Smartsheet, and SharePoint • 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 • Ability to work independently in a collaborative, customer-focused environment • Ability to maintain current knowledge of applicable laboratory, regulatory, accreditation, and quality requirements • Physical ability to sit, stand, use hand and finger dexterity, talk or hear, and use visual acuity to operate equipment, read technical information, and/or use a keyboard • Occasionally exposed to bloodborne and airborne pathogens or infectious materials

🏖️ Benefits

• Equal opportunity employer committed to fostering an inclusive and diverse workplace • Application process accommodations available • Full-time remote work arrangement