Gifthealth · 11 hours ago
Documentation Specialist
Columbus, OH
Full-time
Hybrid
Mid Level
$73K/yr - $86K/yr
3+ years expGifthealth is revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. The Documentation Specialist oversees the pharmacy’s documentation compliance division to ensure adherence to Good Documentation Practices (GDP) and regulatory compliance, while supporting pharmacy teams in achieving operational excellence and compliance standards.
Health CarePharmaceuticalSoftware
Responsibilities
Develops and manage documentation control systems in accordance with Good Documentation Practices (GDP) and regulatory requirements
Creates, updates, and maintains SOPs, templates, and documentation workflows to ensure consistency and compliance
Prepares and organizes documentation for internal and external audits, ensuring all files are accurate, current, and accessible
Conducts regular internal reviews of documentation processes to ensure adherence to data integrity and audit standards
Trains employees on documentation best practices, GDP principles, and audit readiness expectations
Maintains lifecycle control of documents, including version management, archival, and retrieval systems
Supports compliance leadership in continuous improvement of documentation systems and standardization initiatives
Qualification
Required
Bachelor's degree in pharmacy, quality assurance, regulatory affairs, or related field
Minimum 3 years of experience in documentation or compliance within a regulated environment
Knowledge of Good Documentation Practices (GDP) and ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate); FDA and DEA documentation and audit requirements; 21 CFR Parts 11, 210, 211, and 820 regulations; and quality documentation management in a regulated environment
Strong organizational and documentation management skills
Excellent written and verbal communication skills
Ability to interpret and apply complex regulatory requirements
Ability to maintain accuracy and consistency in high-volume, regulated documentation environments
Ability to work collaboratively with compliance and operational teams
Preferred
Certified Quality Auditor (CQA) or equivalent certification
Pharmacy technician or healthcare compliance background
Audit documentation experience in healthcare or pharmaceutical industries
Knowledge of ISO 9001 and GxP frameworks; EudraLex Volume 4, Chapter 4 (Documentation), Annex 11 (Computerized Systems); WHO TRS No. 996, Annex 5, and ICH Q7, Q9, Q10 guidelines
Familiarity with electronic document management systems (EDMS)
Ability to develop document templates, checklists, and control tools to improve documentation efficiency
Company
Gifthealth
GiftHealth is a healthcare tech startup that streamlines pharmacy experience with free delivery and competitive medication pricing.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$45.8MKey Investors
Eir PartnersAllos Ventures
2023-04-04Private Equity· $40M
2021-03-16Seed· $5.8M
2020-06-04Pre Seed
Leadership Team
John Romano
President and Co-Founder
Derek Schneider
CTO
Recent News
2026-01-14
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