Documentation Specialist

Description

About Us

At Gifthealth, we're revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We're a dynamic, innovative, and customer-centric company dedicated to making a positive impact on people's lives.

Position Summary

The Documentation Specialist oversees the pharmacy’s documentation compliance division to ensure adherence to Good Documentation Practices (GDP), data integrity standards, and regulatory compliance. This role establishes and maintains systems and processes that support audit readiness and uphold documentation integrity across all pharmacy operations. The specialist partners closely with the Compliance, Pharmacy Operations, and Quality teams to ensure all records are accurate, controlled, and meet state, federal, and international regulatory requirements.

We are seeking a Documentation Specialist to support our compliance needs. This position plays a key role in supporting our pharmacy teams, ensuring alignment with organizational goals, operational excellence, and compliance standards.

Key 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.

Qualifications

• Education: Bachelor’s degree in pharmacy, quality assurance, regulatory affairs, or related field (Required)
• Licensure/Certification: Certified Quality Auditor (CQA) or equivalent certification (Preferred)
• Experience: 
• Minimum 3 years of experience in documentation or compliance within a regulated environment (Required)
• Pharmacy technician or healthcare compliance background (Preferred)
• Audit documentation experience in healthcare or pharmaceutical industries (Preferred)

• Knowledge, Skills, & Abilities:  
• 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 (Required)
• 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 (Preferred)
• Strong organizational and documentation management skills (Required)
• Excellent written and verbal communication skills (Required)
• Familiarity with electronic document management systems (EDMS) (Preferred)
• Ability to interpret and apply complex regulatory requirements (Required)
• Ability to maintain accuracy and consistency in high-volume, regulated documentation environments (Required)
• Ability to work collaboratively with compliance and operational teams (Required)
• Ability to develop document templates, checklists, and control tools to improve documentation efficiency (Preferred)

Work Environment

• Location: Hybrid 
• Schedule: 8:00 A.M. to 5:00 P.M. Monday through Friday with night and weekend hours on occasion as determined by the needs of the business.
• Regular meetings with internal Compliance, Quality Assurance, Pharmacy Operations, and HR teams. This role may also have limited participation in meetings with external regulatory agencies, auditors, and accreditation body representatives.

Key Essential Functions

• Must be able to remain in a stationary position for extended periods while writing or reviewing documentation
• Must be able to work on a computer for the entire shift
• Must be able to attend virtual meetings with cross-functional teams

Employment Classification

Status: Full-time
FLSA: Exempt  

Equal Employment Opportunity (EEO) Statement

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status. 

We celebrate diversity and are committed to creating an inclusive environment for all employees. If you do not meet every requirement but still feel you would be a great fit for this role, we encourage you to apply!

Disclaimer

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel. Gifthealth reserves the right to modify job duties or descriptions at any time.