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Hims & Hers, a leading health and wellness platform and NYSE-traded public company, is seeking a Quality Systems Document Control Specialist to join the Quality Unit in XeCare Pharmacy. This role supports the document control system and lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations, with emphasis on change control support, SOP development, controlled issuance, review, filing, archival, and compliance tracking.
Key responsibilities include:
- Administering the Document Control System to manage controlled documents such as SOPs, batch records, logbooks, forms, policies, and protocols
- Supporting site-level implementation of change controls and documentation impact assessment
- Designing and enhancing quality system tools and workflows aligned with regulatory requirements
- Issuing and tracking SOPs and controlled documents to ensure only current, approved versions circulate
- Drafting, editing, and formatting SOPs, work instructions, and policies in compliance with USP <795>, <797>, <800>, and FDA 21 CFR 210/211
- Managing SOP lifecycle including periodic review, approval workflows, revision tracking, and retirement of obsolete versions
- Coordinating cross-functional SME reviews involving QA, Production, QC, and Compliance teams
- Ensuring timely 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 and escalating to QA Management
- Preparing documentation packages for regulatory inspections and customer audits
- Supporting continuous improvement of document control processes, including digitization and standardization initiatives
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 a 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 or quality management software
- Strong collaboration skills and ability to work across QA, Production, and Compliance teams
