Quality Systems Document Control Specialist

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.
• 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.
• Support cross-functional SME reviews of SOPs and controlled documents.
• Ensure timely training roll-out when new or revised SOPs are released.
• Maintain both 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.

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.

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.