Cross-Functional Quality 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 position: As the Cross-Functional Quality Specialist, you will serve as a pivotal liaison across Clinical Trials, Laboratory Operations, IT, Materials Management, and other departments as needed to advance a cohesive framework for quality, regulatory compliance, and continuous improvement. This role ensures that processes, documentation, systems, and operations comply with regulatory standards, including FDA (21 CFR Parts 11, 211, 820), ISO 13485, GxP, and CAP, while cultivating a culture of continuous improvement, quality, and operational excellence.

Leveraging comprehensive regulatory expertise, systems thinking, and strong facilitation capabilities, the Cross-Functional Quality Specialist identifies operational risks, leads thorough root cause analyses, and drives the implementation of effective, scalable quality improvements across multiple departments. This position provides critical support for both internal and external audits, manages risk assessments, oversees corrective and preventive action (CAPA) processes, and collaborates closely with departmental leadership to ensure consistent and rigorous execution of quality management practices throughout Arkana.

Beyond traditional compliance oversight, this role functions as a strategic partner and facilitator by translating regulatory requirements into practical, actionable workflows, fostering alignment among cross-functional stakeholders, and enhancing Arkana's preparedness for organizational growth, innovation, and regulatory evaluation.

What you'll do:

• Lead and facilitate quality assurance and compliance initiatives across Clinical Trials, Laboratory Operations, IT, Materials Management, and additional teams as required
• Ensure organizational processes, documentation, and systems comply with FDA regulations, GxP standards, CAP guidelines, and other applicable regulatory standards
• Lead and coordinate internal audits and support external inspections, including preparation, documentation gathering, and response management
• Conduct risk assessments across departments, identify operational risks, and collaborate on development and implementation of mitigation strategies
• Lead and support continuous improvement initiatives, applying Lean, Six Sigma, or other methodologies to enhance process efficiency, reliability, and compliance
• Manage and oversee corrective and preventive action (CAPA) processes, ensuring timely investigations, root cause analysis, and verification of effectiveness
• Facilitate root cause investigations using structured problem-solving methodologies and drive resolution of quality issues
• Develop, review, and maintain controlled quality documentation, including SOPs, work instructions, and training materials, ensuring adherence to document control policie
• Collaborate with IT and operational teams to ensure validation, change control, and compliance of computerized systems and digital platforms
• Track, analyze, and report quality metrics, audit findings, CAPA status, and regulatory compliance trends to leadership and stakeholders
• Deliver quality and compliance training, promote awareness, and foster a culture of accountability, transparency, and continuous improvement across the organization
• Partner with leadership and cross-functional teams to support enterprise-wide quality strategies, ensuring readiness for growth, innovation, and regulatory oversight
• Prepare internal trend analysis of audit observations, addresses audit risks through corrective and preventative actions (internal and external), and identify any compliance risks
• Provide guidance on regulatory compliance to internal clients
• Establish error benchmarking based on relevant industry standards or internal goals
  
  

You should have:

Education: Bachelor's degree in Life Sciences, Health Sciences, Clinical Research, Quality Management, Regulatory Affairs, or a related field is required. Advanced degrees (e.g., Master's, MBA, or relevant certifications such as ASQ CQA, CQE, or Lean Six Sigma) are highly desirable and may serve as a substitute for some experience

Experience: A minimum of 3 years of experience in quality assurance or quality management roles within regulated environments such as healthcare, laboratory operations, clinical trials, contract research organizations (CROs), or medical device manufacturing is required. Candidates should demonstrate proven expertise in applying FDA regulations, ISO 13485, CAP, CLIA, and/or GxP standards, with a track record of successfully leading cross-functional quality initiatives, facilitating audits, and driving continuous improvement projects. Experience collaborating with multidisciplinary teams and managing cross-functional projects is essential

Other Requirements:

• Working knowledge of statistical methods and data visualization sufficient to provide insights into
• performance data
• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing
• priorities and unforeseen events
• Ability to interact professionally and to work independently or in teams
• Ability to prioritize work and define steps needed to achieve assigned project goals
• Strong knowledge of Microsoft Office applications and the ability to learn internal computer
• systems as necessary
• Consistently maintain a professional demeanor (both written and spoken communication) when
• engaging with sponsors, external vendors, and colleagues on behalf of Arkana Laboratories
• Fosters a good working relationship with internal clients and QA team
• Perform other duties as assigned
• Minimal travel may be required
  
  

Schedule: Monday-Friday 8am-5pm onsite at the main office in Little Rock, AR.

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.