AssistRx

CAPA Management Compliance Specialist – Healthcare, Pharma

AssistRx

full-time

Posted on:

Location Type: Remote

Location: Remote • Florida, Montana • 🇺🇸 United States

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Job Level

JuniorMid-Level

About the role

  • 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**

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
CAPA managementroot cause analysisdocumentationrisk assessmentscompliance frameworksinternal auditsexternal auditsversion controlincident managementhealthcare regulations
Soft skills
documentation skillsorganization skillsfollow-up skillswritten communicationverbal communicationattention to detailemotional intelligenceprofessionalismcollaborationcross-functional teamwork
Certifications
CHC certification