Quality Systems Doc Control Specialist — Regulated Pharma

hims & hers; New Albany (OH); On-site; USD 70,000 - 95,000; Full time

Job summary

Hims & Hers is seeking a Quality Systems Document Control Specialist in New Albany to manage the document control system, SOPs, batch records, and policies under 503A regulations. You will drive change controls, ensure current versions, and support regulatory readiness across QA, Production, and Compliance teams.

The role emphasizes SOP lifecycle, training coordination, and aligning workflows with USP and FDA requirements, while maintaining secure filing systems and audit-ready documentation.

Qualifications

• Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent
• 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

Responsibilities

• Support administration of the Document Control System and management of SOPs, batch records, logbooks, forms, policies, and protocols
• Assist site-level change controls and their impact on site documentation and processes
• Help design and enhance quality system tools and workflows in line with regulatory requirements
• Issue and track SOPs and controlled documents, ensuring current approved versions are used
• Draft, edit, and format SOPs, work instructions, and policies for clarity and consistency
• Support SOP lifecycle management including reviews, approvals, revisions, and retirements
• Coordinate cross-functional SME reviews with QA, Production, and Compliance
• Ensure timely training rollout for new or revised SOPs and maintain compliance records
• Maintain electronic and physical filing systems for audit readiness
• Monitor document deviations and escalate to QA Management as needed
• Prepare documentation packs for regulatory inspections and audits
• Partner with QS Management on continuous improvement and digitization projects

Skills

Bachelor's degree

QA experience

SOP drafting

cGMP knowledge

Attention to detail

EDMS familiarity

Cross-functional collaboration

Education

Bachelor’s degree in science/quality/engineering

Tools

EDMS

Job description

Hims & Hers is seeking a Quality Systems Document Control Specialist in New Albany to manage the document control system, SOPs, batch records, and policies under 503A regulations. You will drive change controls, ensure current versions, and support regulatory readiness across QA, Production, and Compliance teams.

The role emphasizes SOP lifecycle, training coordination, and aligning workflows with USP and FDA requirements, while maintaining secure filing systems and audit-ready documentation.