QA Associate

Position Summary

The Quality Assurance Associate - Document Control & Compliance is responsible for supporting document control, customer qualification, regulatory compliance, and record management activities within Medivant Healthcare. This role ensures the accurate maintenance of controlled documentation, customer credential verification, controlled substance order reviews, and compliance record management in accordance with company procedures, regulatory requirements, and quality standards. The ideal candidate is detail-oriented, organized, and capable of managing documentation and compliance activities within a regulated pharmaceutical environment.

Key Responsibilities

Customer Qualification & Compliance Verification

• Perform customer qualification and order vetting activities for controlled substance transactions.
• Verify DEA registrations, state licenses, permits, and other customer credentials.
• Support customer onboarding and qualification processes in accordance with regulatory requirements.
• Review regulatory databases and publicly available information to identify potential compliance concerns.
• Verify customer and business information, including legal entity status, addresses, and licensing information.
• Escalate potential compliance risks or discrepancies for further review.

Document Control & Records Management

• Manage the issuance, tracking, revision, maintenance, and archival of controlled documents.
• Maintain document control systems and ensure proper version control practices.
• Support the preparation, review, distribution, and retention of controlled quality documents.
• Ensure documentation is complete, accurate, and maintained in accordance with company procedures.
• Assist with document retrieval and record requests during audits and inspections.

Compliance Documentation & Recordkeeping

• Maintain compliance records and supporting documentation.
• Manage controlled records including Batch Manufacturing Records (BMRs), logbooks, forms, and compliance-related documentation.
• Ensure records are organized, current, and readily accessible for regulatory and internal review.
• Support documentation reviews to ensure compliance with established procedures and quality standards.
• Assist in maintaining data integrity and documentation best practices.

Quality Systems Support

• Support Manufacturing, Quality Assurance, Regulatory, and Compliance teams with documentation-related activities.
• Assist with quality system processes and related administrative tasks.
• Participate in compliance reviews and documentation audits as assigned.
• Support continuous improvement initiatives related to document control and compliance programs.
• Assist with preparation and organization of records for internal and external audits.

Regulatory Compliance Support

• Ensure compliance with applicable company procedures, regulatory requirements, and industry standards.
• Identify, document, and communicate compliance concerns when identified.
• Support activities related to controlled substance compliance requirements.
• Maintain confidentiality of sensitive business, customer, and compliance information.
• Perform additional duties and special projects as assigned.

Qualifications

Required

• High School Diploma or equivalent required; Associate Degree preferred.
• Minimum one (1) year of experience in document control, compliance, quality, manufacturing, healthcare, administration, or another regulated environment.
• Strong attention to detail and organizational skills.
• Proficiency with Microsoft Office applications and document management systems.
• Excellent written and verbal communication skills.
• Ability to maintain confidentiality and handle sensitive information appropriately.
• Ability to work independently while managing multiple priorities and deadlines.
• Strong recordkeeping and documentation skills.

Preferred

• Experience in pharmaceutical, GMP-regulated, healthcare, or other regulated industries.
• Knowledge of document control processes and controlled record management practices.
• Experience using electronic document management systems (EDMS).
• Familiarity with DEA registrations, controlled substance requirements, and state licensing regulations.
• Understanding of quality systems and regulatory compliance requirements.

Key Competencies

• Document Control & Records Management
• Regulatory Compliance
• Customer Qualification & Verification
• Controlled Substance Compliance
• Attention to Detail
• Documentation Accuracy
• Data Integrity
• Analytical & Verification Skills
• Recordkeeping Excellence
• Problem Solving
• Organization & Time Management
• Confidentiality & Professionalism
• Cross-Functional Collaboration
• Communication Skills
• Continuous Improvement Mindset

What Success Looks Like

• Customer qualification and license verification activities are completed accurately and on time.
• Controlled documents and records are maintained in an organized, compliant, and audit-ready state.
• Compliance records are accurate, complete, and readily accessible.
• Potential compliance risks and documentation discrepancies are identified and escalated appropriately.
• Document control processes operate efficiently with proper version control and record retention.
• Internal and external audit requests are supported effectively through accurate documentation management.
• Strong collaboration is maintained with Quality, Manufacturing, Compliance, and Regulatory teams.
• Regulatory requirements and company quality standards are consistently upheld.
• Documentation practices support operational excellence, compliance, and inspection readiness.