Quality Systems & SOP Control Specialist

Hims & Hers Health, Inc.; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Hims & Hers Health, Inc. in New Albany, OH, is seeking a Quality Systems Document Control Specialist to join our Quality Unit.

This role focuses on supporting the document control system and lifecycle of controlled documents in a 503A compounding pharmacy, with emphasis on change control, SOP development, and compliance tracking. You will manage SOPs, batch records, and forms; assist in drafting and formatting procedures aligned with USP 795, 797, 800, and FDA 21 CFR 210/211; drive document

Qualifications

• Bachelor’s degree preferred in science, quality, or engineering.
• 3+ years in quality, manufacturing, or regulated industry.
• Hands-on SOP drafting and controlled-document systems.
• Deep knowledge of cGMP, USP standards, and FDA record-keeping.
• Excellent editing, writing, and organizational skills.
• Familiarity with EDMS or quality management software.
• Strong collaboration across QA, Production, and Compliance.

Responsibilities

• Support administration of the Document Control System and control documents.
• Assist change controls and impact on site documentation and processes.
• Help design quality system tools and workflows for regulatory alignment.
• Issue and track SOPs, ensuring current approved versions are used.
• Draft, edit, and format SOPs, work instructions, and policies.
• Manage SOP lifecycle: reviews, approvals, revisions, retirement.
• Coordinate cross-functional SME reviews with QA, Production, Compliance.
• Ensure timely training roll-out and maintain audit-ready records.
• Maintain electronic and physical filing systems for easy retrieval.
• Monitor document-related deviations and escalate to QA management.
• Prepare documentation packages for inspections and audits.
• Partner with QS Management to improve document control processes.

Skills

SOP drafting

EDMS experience

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Education

Bachelor’s degree preferred

Equivalent combination of education and experience

Tools

EDMS software

Job description

Hims & Hers Health, Inc. in New Albany, OH, is seeking a Quality Systems Document Control Specialist to join our Quality Unit.

This role focuses on supporting the document control system and lifecycle of controlled documents in a 503A compounding pharmacy, with emphasis on change control, SOP development, and compliance tracking. You will manage SOPs, batch records, and forms; assist in drafting and formatting procedures aligned with USP 795, 797, 800, and FDA 21 CFR 210/211; drive document