Quality Systems Document Control Specialist

Hims & Hers • Mesa, AZ

7d

About The Position

Hims & Hers is hiring a Quality Systems Document Control Specialist to join the Quality Unit in XeCare Pharmacy. The role supports the document control system and the lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations. With a particular 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.

The specialist administers document control activities, supports site-level implementation of change controls and their impact on documentation and processes, and helps improve quality-system tools and workflows. The role works with QA, Production, QC, Compliance, Training, Operations, and Quality Systems Management to maintain accurate, current, audit-ready documentation and support continuous improvement.

Requirements

• Bachelor’s degree in a relevant discipline, such as science, quality, or engineering, preferred; an equivalent combination of education and experience is acceptable.
• Hands-on experience drafting and formatting SOPs and using 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 engineering.

Responsibilities

• Support administration of the Document Control System and management of controlled 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 aligned 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.
• Support SOP lifecycle management, including periodic reviews, approval workflows, revision history tracking, and retirement of obsolete versions.
• Coordinate cross-functional SME reviews of SOPs and controlled documents, incorporating input from QA, Production, QC, and Compliance.
• Ensure timely training rollout for new and revised SOPs and maintain compliance records in coordination with the Training department and Operations teams.
• Maintain electronic and physical filing systems for secure storage, 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.

Benefits

• Comprehensive health benefits, including medical, dental, and vision coverage
• Parental leave
• 401k benefits with employer matching contribution

What This Job Offers

• Job Type: Full-time