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Hims & Hers, a leading telehealth and wellness platform (NYSE: HIMS), is seeking a Quality Systems Document Control Specialist to join the Quality Unit at its New Albany compounding pharmacy facility. This role is central to maintaining regulatory compliance and operational excellence in a 503A-regulated pharmacy environment.
You will manage the complete lifecycle of controlled documentation, including SOPs, batch records, logbooks, forms, policies, and protocols. Key responsibilities include:
• Administering the document control system and ensuring proper management of all controlled documents
• Supporting site-level change control implementation and documenting impacts to processes
• Designing and enhancing quality system tools and workflows to align with regulatory requirements
• Issuing, tracking, and maintaining current versions of SOPs and controlled documents in circulation
• Drafting, editing, and formatting SOPs and work instructions in compliance with USP <795>, <797>, <800>, and FDA 21 CFR 210/211
• Managing the full SOP lifecycle: periodic review, approval workflows, revision tracking, and retirement of obsolete versions
• Coordinating cross-functional SME reviews involving QA, Production, QC, and Compliance teams
• Supporting training rollout for new or revised SOPs and maintaining compliance records
• Maintaining electronic and physical filing systems for secure storage, easy retrieval, and audit readiness
• Monitoring document-related deviations (missing signatures, uncontrolled copies, outdated references) and escalating to QA Management
• Preparing documentation packages for regulatory inspections and customer audits
• Partnering with QS Management on continuous improvement, including digitization and standardization initiatives
This is a hands-on role requiring strong attention to detail, excellent writing and organizational skills, and the ability to collaborate across multiple departments in a regulated manufacturing environment.
REQUIREMENTS:
• Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field), or equivalent combination of education and experience
• 3+ years of related experience in quality, manufacturing, or a regulated industry (may substitute for degree)
• Hands-on experience with SOP drafting, formatting, and controlled documentation systems
• In-depth knowledge of cGMP documentation practices, USP standards, and FDA record-keeping requirements
• Exceptional attention to detail with strong editing, writing, and organizational skills
• Familiarity with electronic document management systems (EDMS) or validated document control/quality management software
• Strong collaboration skills and ability to work across QA, Production, and Compliance teams
