Specialist, Compounding Operations Documentation

About the role

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” The Compounding Operations Documentation Specialist is responsible for the creation, review, control, and continuous improvement of documentation related to compounding activities. This role ensures accurate and compliant recording of batch production activities, supports timely document turnaround, and upholds documentation practices in alignment with compliance, USP 795/800, 503A, and internal quality systems. This is an on-site role at our New Albany facility.

Responsibilities

• Assist in drafting, revising, and formatting manufacturing documentation, including SOPs, work instructions, logs, forms, and compounding protocols.
• Ensure document revisions are properly controlled, approved, and issued in alignment with document control procedures.
• Maintain documentation archives and ensure real-time filing and retrieval practices.
• Ensure all documentation activities are aligned with regulatory requirements (FDA, EU, etc.) and internal QMS standards.
• Maintain compliance with USP , , and (as applicable) and other regulatory guidelines.
• Participate in audits and inspections by preparing and presenting relevant documents upon request.
• Support data integrity initiatives and ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Collaborate with production and quality teams to support continuous improvement of documentation processes.
• Partner with compounding operators and supervisors to identify points for training.
• Help transition paper-based processes to electronic formats (if applicable).

Qualifications

• Bachelor’s degree in English / Communications, Technical Writing / Tech Comm Pharmaceutical Technology, Chemistry, Pharmacy or a related field.
• Strong knowledge of USP 795 and 800, cGMP, GDP, and compliance
• Detail-oriented with excellent proofreading and technical writing skills.
• Proficiency in Google Suite and experience in Asana, SmartSheet

Skills

• Working familiarity with compounding processes, equipment, and terminology.
• Experience in electronic batch records (EBR) and manufacturing execution systems (MES