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CAPA Management Compliance Specialist (Healthcare / Pharma)

CAPA Management Compliance Specialist (Healthcare / Pharma)

AssistRxMaitland, FL, US
2 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

At AssistRx , we combine advanced technology and human insight to simplify patient access and improve health outcomes. Our Compliance team plays a critical role in ensuring that every process, system, and partnership upholds the highest standards of integrity, privacy, and regulatory compliance.

We are seeking a Compliance Specialist with proven CAPA management experience to help strengthen our quality and risk framework across the organization. This role is ideal for a detail-oriented professional who thrives in a dynamic, mission-driven healthcare technology environment.

Key Responsibilities

  • Lead and support Corrective and Preventive Action (CAPA) investigations—driving root cause analysis, documentation, follow-up, and verification of effectiveness.
  • Assist the Compliance Manager with internal reviews, audits, and risk assessments to ensure adherence to laws, client requirements, and certification standards (HIPAA, SOC2, URAC, etc.).
  • Document findings and trends from audits and assessments to identify and mitigate risk areas.
  • Manage day-to-day operations of the Document Management System (DMS) and Learning Management System (LMS) , ensuring timely updates and version control.
  • Collaborate with cross-functional teams to track CAPA progress , monitor action item completion, and prepare evidence for internal and external audits.
  • Participate in incident management , ensuring issues are logged, investigated, and closed out with appropriate preventive actions.
  • Maintain compliance and privacy logs, and support training and communication initiatives across the enterprise.
  • Stay informed on federal and state healthcare regulations , client requirements, and emerging compliance trends.

Requirements

  • 2+ years of CAPA management experience in a regulated industry (healthcare, pharma, or health-tech preferred).
  • Strong understanding of compliance frameworks such as HIPAA, SOC2, URAC, or ISO.
  • Experience supporting or leading internal and external audits .
  • Bachelor’s degree in business, healthcare administration, or related field (or equivalent experience).
  • Excellent documentation, organization, and follow-up skills.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio); Jira Service Desk experience a plus.
  • Strong written and verbal communication skills with high attention to detail.
  • High emotional intelligence, professionalism, and ability to work effectively in cross-functional teams.
  • CHC certification or related compliance credential preferred.
  • Benefits

  • Supportive, progressive, fast-paced environment
  • Competitive pay structure
  • Matching 401(k) with immediate vesting
  • Medical, dental, vision, life, & short-term disability insurance
  • Opportunity to impact patient outcomes through data-driven healthcare technology.
  • Collaborative and mission-driven culture that values innovation and continuous learning.
  • Access to cutting-edge cloud technologies and modern data engineering tools.
  • Competitive compensation, comprehensive benefits, and career growth opportunities
  • AssistRx, Inc. is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit based factors, or any other protected categories protected by federal, state, or local laws.

    All offers of employment with AssistRx are conditional based on the successful completion of a pre-employment background check.

    In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Sponsorship and / or work authorization is not available for this position.

    AssistRx does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of AssistRx and no fee will be paid in the event of a hire

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    Compliance Specialist • Maitland, FL, US

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