Validation and Vendor Specialist

Arkana Laboratories • Arkansas, AR

3d

About The Position

The Validation and Vendor Specialist is part of Arkana Laboratories’ Quality Assurance team and is responsible for keeping regulated computerized systems and vendor relationships compliant and audit-ready. The role owns the computerized system validation lifecycle and vendor qualification program, ensuring alignment with applicable laboratory, privacy, and regulatory requirements. It also advises internal stakeholders and supports regulatory audits.

Requirements

• Bachelor's degree in a science, healthcare, IT, quality, or related field.
• At least 2 years in a compliance, validation, or quality role in a laboratory, healthcare, or regulated setting.
• 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.

Responsibilities

• 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 determine the appropriate 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 warranted.
• 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 retrieving validation and vendor records.
• Perform other duties as assigned.

Benefits

• Competitive salary
• Generous paid time off and paid holidays
• Minimal-cost health insurance for the employee and affordable family options
• 401(k) with immediate eligibility and employer 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level