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- Monitor document-related deviations, including missing signatures, uncontrolled copies, or outdated references, and escalate to QA Management for corrective action.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