Specialist, Compounding Operations Documentation

Hims & Hers • New Albany, OH

4d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• Working familiarity with compounding processes, equipment, and terminology.
• Experience in electronic batch records (EBR) and manufacturing execution systems (MES).
• Ability to handle multiple priorities with a strong sense of urgency and accuracy.
• Strong interpersonal and communication skills, especially when liaising between Compounding and QA teams.
• Good Manufacturing Practices (cGMP) experience.
• 3–5 years of experience in a cGMP manufacturing environment, preferably with compounding or formulation experience.
• Document control systems (e.g., MasterControl, Veeva, Agile) experience.

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 <797>, and <800> (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).

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level