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Specialist, Compounding Operations Documentation

Hims & Hers· PHARMACY
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New Albany, OhioFull-timePosted 2w ago

About the role

Specialist responsible for creation, review, control, and continuous improvement of documentation related to compounding activities, ensuring accurate and compliant recording of batch production activities in alignment with USP standards and internal quality systems.

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 <795>, <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).

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

Required:Documentation developmentDocument controlRegulatory complianceALCOA+ data integrity
Nice to have:Training & collaboration

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
Last updated Oct 7, 2026. Interested? Apply on the company site.

About Hims & Hers

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