Quality Systems & Document Control Specialist

K1 Industries; New Albany (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Hims & Hers is seeking a Quality Systems Document Control Specialist to support the document control lifecycle within a 503A compounding pharmacy, focusing on change control, SOP development, and regulatory compliance.

You will manage SOP issuance, drafting, formatting, and filing, maintain electronic and physical records, track revisions, and coordinate cross-functional reviews with QA, Production, QC, and Compliance to ensure audit readiness.

Qualifications

• Bachelor’s degree preferred in science, quality, or engineering; or equivalent experience.
• 3+ years in quality, manufacturing, or a regulated industry may substitute for a degree.
• Hands-on experience with SOP drafting, formatting, and controlled documentation systems.

Responsibilities

• Support the administration of the Document Control System, managing SOPs, batch records, logbooks, forms, policies, and protocols.
• Assist in change controls and assess impact on site documentation and processes.
• Draft, edit, format, and ensure alignment of SOPs and work instructions with USP standards and FDA requirements.

Skills

SOP drafting

EDMS

cGMP documentation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree preferred

3+ years in quality/regulatory

Tools

EDMS

Document control software

Job description

Hims & Hers is seeking a Quality Systems Document Control Specialist to support the document control lifecycle within a 503A compounding pharmacy, focusing on change control, SOP development, and regulatory compliance.

You will manage SOP issuance, drafting, formatting, and filing, maintain electronic and physical records, track revisions, and coordinate cross-functional reviews with QA, Production, QC, and Compliance to ensure audit readiness.