Senior Validations Specialist

Our mission is to build a healthier and more connected world with precision health and genealogy services. We empower individuals with actionable insights into their genetic makeup, fostering a deeper understanding of their ancestry, health, and wellness. By integrating the experience of Gene by Gene Laboratory Services, FamilyTreeDNA genealogy, and myDNA reporting services, we strive to deliver cutting-edge genetic testing and personalized solutions that inspire informed decisions and enhance quality of life. Our team is dedicated to advancing the field of genomics through innovation, research, and a commitment to excellence.

All employees are expected to demonstrate our values of Innovate, One Team, and Integrity when carrying out the accountabilities and responsibilities of their role. This is how we show up every day for ourselves, our colleagues and our customers and strategic partners to deliver our vision and strategic goals.

The Senior Validations Specialist is responsible for the analysis and interpretation of genetic data using computational and statistical methods, and for the validation activities that ensure our assays, pipelines, and data systems are accurate, reliable, and ready for use. Working with large-scale genomic data sets, this role identifies patterns and trends, implements quality control measures, and uses a variety of bioinformatics tools - developing new software applications where needed to solve problems in the field of genomics.

• Design, execute, and document validation and verification studies for assays, bioinformatics pipelines, instruments, and data analysis workflows in line with regulatory and accreditation requirements.
• Define acceptance criteria, analyze validation data, and prepare clear, well-organized validation reports documenting the performance metrics of pipelines and products, ensuring that they are in compliance with required quality guidelines. 
• Drive validation activities to completion with urgency, proactively removing roadblocks and keeping stakeholders informed of progress and risks.

• Analyze and interpret large-scale biological and genomic data sets using computational and statistical methods.
• Identify patterns, trends, and anomalies in sequencing and genotyping data, and translate findings into actionable recommendations.
• Apply sound statistical rigor to study design, data analysis, and interpretation of results.

• Implement and maintain quality control measures to ensure the accuracy, reliability, and reproducibility of collected data.
• Monitor pipeline performance metrics, investigate deviations, and lead root-cause analysis with a solutions-first mindset.
• Support internal and external audits, inspections, and accreditation activities as they relate to validated systems and data.
• Write, review, and update standard operating procedures relevant to validation and quality control procedures in compliance with regulatory requirements.

• Use a variety of bioinformatics tools and platforms; evaluate, select, and configure tools to fit business and scientific needs.
• Document tools, pipelines, and processes so that knowledge is shared and work is repeatable across the team.

• Work independently on moderately complex aspects of projects while collaborating closely with laboratory, quality, and product teams.
• Contribute to a lean, efficient way of working by simplifying processes, eliminating redundant steps, and sharing improvements across teams.
• Bring energy, ownership, and a can-do attitude to cross-functional initiatives, helping the team move quickly without compromising quality.

• Strong knowledge of bioinformatics tools, pipelines, software, and databases used in genomics (e.g., NGS and genotyping analysis workflows), including proficiency in Linux/UNIX environments
• Working knowledge and understanding of molecular biology and genetic laboratory testing workflows
• Proficiency in computational and statistical methods for analyzing large-scale biological data sets
• Thorough knowledge of quality control principles, validation and verification practices, and regulatory standards published by national and  international accrediting programs (e.g., CLIA, CAP, COLA, NYSDOH, ISO 15189, ISO/IEC 17025, UKAS, etc.)
• Proven experience drafting technical validation plans, summary reports, and standard operating procedures in a regulated clinical laboratory environment
• Clear written and verbal communication, with strong documentation habits
• A sense of urgency, a solutions-first mindset, and the resourcefulness to thrive in a lean, fast-moving environment

• Typically requires 4-7 years of related experience in bioinformatics, genomics data analysis, laboratory process validation and quality assurance, and/or regulatory compliance, within a laboratory or biotechnology setting
• Demonstrated ability to work independently and collaboratively, contributing to complex aspects of projects

• Ph.D. or M.S. degree in Genetics, Bioinformatics, Computational Biology, or a related field required

•  Bioinformatics and Data Science teams
• Laboratory Operations 
• Quality Assurance and Regulatory Affairs
• Research and Development / Product teams 
• IT and Software Engineering

• Accreditation and regulatory bodies (e.g., CAP, CLIA) during audits and inspections
• Instrument, reagent, and software vendors
• External collaborators and reference laboratories, as required

• Selection of analytical methods, statistical approaches, and bioinformatics tools for assigned work.
• Design details of validation and verification studies within approved protocols.
• Day-to-day prioritization and sequencing of tasks within assigned projects.
• Identification and escalation of data quality issues and validation risks.

• Final acceptance and release of validated assays, pipelines, or systems (with Quality and management).
• Changes to SOPs, validated processes, or regulated workflows.
• Significant tool, software, or infrastructure purchases.
• Project scope, timeline, and resourcing changes.