Hims & Hers
Quality Systems Document Control Specialist
New Albany, Ohio · On-site · Full-time · Posted Oct 23, 2026
- Experience
- 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
- Education
- Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience.
About the job
Supports controlled-document systems and change control for a 503A compounding pharmacy, maintaining compliant document lifecycles and audit readiness.
What you'll do
- Administer controlled documents, including SOPs, batch records, forms, and policies; manage issuance, review, revision, filing, and archiving.
- Support site change controls and SOP drafting, implementation, training, and compliance tracking.
- Prepare documentation for inspections and audits, monitor document-related deviations, and contribute to process improvements.
What they ask for
- Hands-on experience drafting and formatting SOPs and working with controlled documentation systems.
- In-depth knowledge of cGMP documentation practices, USP standards, and FDA record-keeping requirements.
- Strong editing, writing, organizational, attention-to-detail, and collaboration skills.
- Familiarity with electronic document management systems (EDMS) or validated document control or quality management software.
Nice to have
- Bachelor’s degree in a relevant discipline (science, quality, or engineering-related field).
Pay
$30 – $40 per hour (base salary)
Tools
EDMS, USP <795>, USP <797>, USP <800>, FDA 21 CFR 210/211
Model-written summary · the original posting is authoritative