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Hims & Hers, a leading telehealth and wellness platform (NYSE: HIMS), is seeking a Specialist in Compounding Operations Documentation to join its New Albany, Ohio facility. This is an on-site role focused on creating, reviewing, controlling, and continuously improving documentation related to compounding activities.
You will be responsible for ensuring accurate and compliant recording of batch production activities, supporting timely document turnaround, and upholding documentation practices aligned with compliance standards including USP 795/800, 503A, and internal quality systems.
Key responsibilities include:
- Drafting, revising, and formatting manufacturing documentation (SOPs, work instructions, logs, forms, compounding protocols)
- Ensuring proper document control, approval, and issuance in alignment with established procedures
- Maintaining documentation archives with real-time filing and retrieval practices
- Ensuring all documentation aligns with FDA, EU, and internal QMS standards
- Maintaining compliance with USP <795>, <797>, and <800> standards and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)
- Supporting audits and inspections by preparing and presenting relevant documents
- Collaborating with production and quality teams to identify training needs and improve documentation processes
- Assisting in transitioning paper-based processes to electronic formats
The role involves office and manufacturing environment exposure, including potential gowning and entry into classified cleanroom areas. You will work with hazardous drugs and must wear appropriate PPE (gloves, respiratory protection, gown). Medical approval is required to wear respiratory protection. Physical requirements include walking up to 50% of the time, standing up to 100%, squatting/bending up to 20%, and lifting up to 50 lbs for up to 12-hour shifts.
Qualifications:
- Bachelor's degree in English/Communications, Technical Writing, Pharmaceutical Technology, Chemistry, Pharmacy, or related field
- Strong knowledge of USP 795 and 800, cGMP, GDP, and compliance requirements
- Detail-oriented with excellent proofreading and technical writing skills
- Proficiency in Google Suite and experience with Asana or SmartSheet
- 3–5 years of experience in a cGMP manufacturing environment, preferably with compounding or formulation experience
Preferred skills:
- Working familiarity with compounding processes, equipment, and terminology
- Experience with electronic batch records (EBR) and manufacturing execution systems (MES)
- Document control systems experience (MasterControl, Veeva, Agile)
- Ability to handle multiple priorities with strong sense of urgency and accuracy
- Strong interpersonal and communication skills, especially between Compounding and QA teams
