# Quality Systems Document Control Specialist **Company**: Hims & Hers **Location**: Gilbert, Arizona; Mesa, Arizona **Work arrangement**: onsite **Job type**: Full time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://jobs.ashbyhq.com/hims-and-hers/056755b5-5359-4970-9731-3a82243164a4?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_9a363576-691 ## Description Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are looking for a Quality Systems Document Control Specialist to join our Quality Unit in XeCare Pharmacy. This role is responsible for supporting the document control system and lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations. ## Responsibilities: - Support the administration of the Document Control System, ensuring proper management of controlled documents such as SOPs, batch records, logbooks, forms, policies, and protocols. - Support the site level implementation of change controls and the impact to site documentation and defined processes. - Support the design and enhancement of quality system tools and workflows, ensuring alignment with regulatory requirements and business needs. - Issue and track SOPs and other controlled documents, ensuring only current, approved versions are in circulation. - Assist in drafting, editing, and formatting SOPs, work instructions, and policies, ensuring clarity, consistency, and alignment with USP <795>, <797>, <800>, and FDA 21 CFR 210/211. - Support SOP lifecycle management, including periodic review, approval workflows, revision history tracking, and retirement of obsolete versions. - Support cross-functional SME reviews of SOPs and controlled documents, ensuring input from QA, Production, QC, and Compliance. - Ensure timely training roll-out when new or revised SOPs are released, and maintain records to demonstrate compliance in alignment with the Training department and Operations teams. - Maintain both electronic and physical filing systems, ensuring secure storage, easy retrieval, and audit readiness. - Monitor document-related deviations, including missing signatures, uncontrolled copies, or outdated references, and escalate to QA Management for corrective action. - Prepare and provide documentation packages for regulatory inspections and customer audits. - Partner with QS Management to support continuous improvement of the document control process, including digitization initiatives and standardization projects. ## 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, with the ability to work across QA, Production, and Compliance teams. ## Benefits: - Comprehensive health benefits including medical, dental & vision, and parental leave - 401k benefits with employer matching contribution ## Skills ### Required - SOP drafting - controlled documentation systems - cGMP documentation practices - USP standards - FDA record-keeping requirements - electronic document management systems (EDMS) - quality management software --- Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/056755b5-5359-4970-9731-3a82243164a4?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)