Arkana Laboratories

Clinicopathologic consultations to improve patient care

Validation and Vendor Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeArkansas, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in a science, healthcare, information technology, quality, or related field is required.
At least 2 years of experience in a compliance, validation, or quality role in a laboratory, healthcare, or regulated setting is required.
Demonstrated experience authoring validation documentation is required.
Experience with 21 CFR Part 11 and GxP requirements is required.
Experience owning or contributing to a vendor qualification or supplier management program is required.

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 scope 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 revalidate 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 retrieving validation and vendor records.
Perform other duties as assigned.

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.

About the Company

Arkana Laboratories

Clinicopathologic consultations to improve patient care

Arkana Laboratories provides specialized pathology services with a focus on esoteric pathology to support patient care. Their offerings center on high-quality clinicopathologic discussions and close collaboration with clinicians, treating the lab as an extension of a doctor’s practice to help deliver timely, accurate biopsy interpretations. Their approach emphasizes fast, clear communication of results and expert interpretation to guide patient treatment. Unlike typical labs, Arkana positions itself as a partner in care, prioritizing the clinician’s needs and the patient’s outcome over volume. The company’s goal is to shorten the time from biopsy to result and equip doctors with precise information to deliver the most effective care.

Company size: 51-200
Company stage: Grant
Total funding: $4.7M
Headquarters: Little Rock, AR
Founded: 2001

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