Quality Systems Document Control Specialist

Hims & Hers • New Albany, OH

1d • $30 - $40

About The Position

Hims & Hers is seeking a Quality Systems Document Control Specialist to join the Quality Unit for Hims in New Albany. The role supports the document control system and the lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations. With an emphasis on Change Control support, SOP development, controlled issuance, review, filing, archival, and compliance tracking, the Specialist helps ensure documentation meets regulatory requirements and supports operational excellence.

Requirements

• Bachelor’s degree preferred in a relevant discipline, such as science, quality, or an engineering-related field, or an equivalent combination of education and experience.
• Three or more 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 and 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.

Nice To Haves

• Bachelor’s degree in a relevant discipline, such as science, quality, or an engineering-related field.

Responsibilities

• Support administration of the Document Control System, managing controlled documents such as SOPs, batch records, logbooks, forms, policies, and protocols.
• Support site-level implementation of change controls and assess their impact on site documentation and defined processes.
• Support the design and enhancement of quality system tools and workflows in 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 for 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, gathering input from QA, Production, QC, and Compliance.
• Ensure timely training rollout for new or revised SOPs and maintain compliance records in coordination with the Training department and Operations teams.
• Maintain electronic and physical filing systems for secure storage, easy retrieval, and audit readiness.
• Monitor document-related deviations, such as missing signatures, uncontrolled copies, or outdated references, and escalate them to QA Management for corrective action.
• Prepare and provide documentation packages for regulatory inspections and customer audits.
• Partner with QS Management on continuous improvement of document control, including digitization initiatives and standardization projects.

What This Job Offers

• Job Type: Full-time