Validation and Vendor Specialist

Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most. This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field. Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.About the Role As Arkana’s Validation and Vendor Specialist, you’ll keep our regulated computerized systems and vendor relationships compliant and audit-ready, owning both the system validation lifecycle and the vendor qualification program within the Quality Assurance team. What You'll Do Own the end-to-end validation lifecycle for regulated computerized systems, from risk-based classification through IQ/OQ/PQ execution, documentation, and periodic review. Classify systems by risk to scope the right validation approach. Maintain the GxP computerized systems inventory and keep new and existing tools audit-ready. Partner with department leads on system configuration and deployment. Conduct impact assessments after system or vendor changes, and re-validate systems when changes warrant it. Schedule and complete periodic reviews for validated systems. Own the vendor qualification program, including risk-ranking vendors, qualifying new vendors before onboarding, and requalifying existing vendors on a defined cadence. Collect and maintain vendor documentation. Monitor vendor recalls and field notifications, and drive corrective actions to closure. Ensure validated systems and vendor practices align with CAP and NY DOH CLEP standards for laboratory information and computerized systems. Assess vendor and system compliance with HIPAA safeguards for PHI, and support HITRUST control alignment for in-scope systems and vendor assessments. Track evolving GxP and Part 11 requirements that affect Arkana’s systems. Advise internal stakeholders on validation and compliance questions. Support regulatory audits by pulling validation and vendor records. Other duties as assigned. What We're Looking For Education Bachelor's degree in a science, healthcare, IT, quality, or related field. Experience 2+ years in a compliance, validation, or quality role in a laboratory, healthcare, or regulated setting. Other Requirements:  Demonstrated experience authoring validation documentation. Experience with 21 CFR Part 11 GxP requirements. Experience owning or contributing to a vendor qualification or supplier management program. What we offer: We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings. Specifically, we offer the following benefits to full-time employees: Competitive salary Generous paid time off and Paid Holidays Minimal cost health insurance for you and affordable options for your family 401(k) with immediate eligibility and match Company-paid life insurance Company-paid long term disability coverage Affordable vision and dental plans Flexible Spending Account or Health Savings Account availability Wellness plan and complimentary yoga classes Monthly in-office massages and employer-sponsored lunches Please see Careers for further information.