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Quality Document Control Specialist

Full-time

Hims & Hers

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 redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. To learn more about the brand and offerings, you can visit hims.For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit . Quality Systems Document Control Specialist to join our Quality Unit for Hims in New Albany. supporting the document control system and lifecycle of controlled documents SOP development, controlled issuance, review, filing, archival, and compliance tracking , the Document Control Specialist ensures that all documentation meets regulatory requirements and supports operational excellence. 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

  • SOP lifecycle management , including periodic review, approval workflows, revision history tracking, and retirement of obsolete versions.
of SOPs and controlled documents, ensuring input from QA, Production, QC, and Compliance. 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. document-related deviations , including missing signatures, uncontrolled copies, or outdated references, and escalate to QA Management for corrective action. for regulatory inspections and customer audits. continuous improvement of the document control process , including digitization initiatives and standardization projects. 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. SOP drafting, formatting, and controlled documentation systems . editing, writing, and organizational skills . 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. We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our

Vacancy posted 3 hours ago
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