Quality Systems Document Control Specialist

Hims & Hers Health, Inc.; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Hims & Hers Health, Inc. in New Albany, OH, is seeking a Quality Systems Document Control Specialist to join our Quality Unit.

This role focuses on supporting the document control system and lifecycle of controlled documents in a 503A compounding pharmacy, with emphasis on change control, SOP development, and compliance tracking. You will manage SOPs, batch records, and forms; assist in drafting and formatting procedures aligned with USP 795, 797, 800, and FDA 21 CFR 210/211; drive document

Qualifications

• Bachelor’s degree preferred in science, quality, or engineering.
• 3+ years in quality, manufacturing, or regulated industry.
• Hands-on SOP drafting and controlled-document systems.
• Deep knowledge of cGMP, USP standards, and FDA record-keeping.
• Excellent editing, writing, and organizational skills.
• Familiarity with EDMS or quality management software.
• Strong collaboration across QA, Production, and Compliance.

Responsibilities

• Support administration of the Document Control System and control documents.
• Assist change controls and impact on site documentation and processes.
• Help design quality system tools and workflows for regulatory alignment.
• Issue and track SOPs, ensuring current approved versions are used.
• Draft, edit, and format SOPs, work instructions, and policies.
• Manage SOP lifecycle: reviews, approvals, revisions, retirement.
• Coordinate cross-functional SME reviews with QA, Production, Compliance.
• Ensure timely training roll-out and maintain audit-ready records.
• Maintain electronic and physical filing systems for easy retrieval.
• Monitor document-related deviations and escalate to QA management.
• Prepare documentation packages for inspections and audits.
• Partner with QS Management to improve document control processes.

Skills

SOP drafting

EDMS experience

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Education

Bachelor’s degree preferred

Equivalent combination of education and experience

Tools

EDMS software

Job 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 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.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role:

We are looking for a Quality Systems Document Control Specialist to join our Quality Unit for Hims in New Albany. This role is responsible for supporting the document control system and lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations. With a strong emphasis on Change Control support, 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.

You Will:

• 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 elevate 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.

You Have:

• 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.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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