Hims And Hers
Quality Systems Document Control Specialist
Gilbert, Arizona. Posted 29 days ago
The role
This person will support the document control system and lifecycle of controlled documents in a compounding pharmacy. They will focus on change control support, SOP development, and compliance tracking.
What you will do
- Support the administration of the Document Control System for SOPs, batch records, logbooks, forms, policies, and protocols.
- Support site level implementation of change controls.
- Support the design and enhancement of quality system tools and workflows.
- Issue and track SOPs and other controlled documents.
- Assist in drafting, editing, and formatting SOPs, work instructions, and policies.
- Support SOP lifecycle management including review, approval, and retirement.
- Support cross-functional SME reviews of SOPs and controlled documents.
- Ensure timely training roll-out when new or revised SOPs are released.
- Maintain electronic and physical filing systems.
- Monitor document-related deviations and escalate to QA Management.
Required qualifications
- 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 to work across QA, Production, and Compliance teams.
Nice to 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.
Benefits
- Comprehensive health benefits including medical, dental & vision
- Parental leave
- 401k benefits with employer matching contribution
About the company
Hims & Hers is a health and wellness platform that provides access to personalized care. It is a public company traded on the NYSE.