# Quality Systems Document Control Specialist

**Company**: Hims & Hers
**Location**: New Albany, Ohio
**Work arrangement**: onsite
**Job type**: Full time
**Salary**: $30 – $40 per hour
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://jobs.ashbyhq.com/hims-and-hers/2d9532e8-4af6-4897-a1eb-b84cc5a5af66?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_cdfca7af-f08

## Description

We are looking for a Quality Systems Document Control Specialist to join our Quality Unit in New Albany.

The successful candidate will support the document control system and lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations.

Responsibilities include:

- Supporting the administration of the Document Control System

- Implementing change controls and assessing their impact on site documentation and processes

- Designing and enhancing quality system tools and workflows

- Issuing and tracking SOPs and other controlled documents

- Drafting, editing, and formatting SOPs, work instructions, and policies

- Managing SOP lifecycles, including periodic review and approval workflows

- Supporting cross-functional SME reviews of SOPs and controlled documents

- Ensuring timely training roll-out for new or revised SOPs

- Maintaining electronic and physical filing systems

- Monitoring document-related deviations and escalating to QA Management

- Preparing documentation packages for regulatory inspections and customer audits

- Collaborating with QS Management to improve the document control process

Requirements:

- Bachelor's degree in a relevant discipline (science, quality, or engineering-related field)

- 3+ years of experience in quality, manufacturing, or a regulated industry

- 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

## Skills

### Required
- SOP drafting
- controlled documentation systems
- cGMP documentation practices
- USP standards
- FDA record-keeping requirements
- electronic document management systems

### Nice to have
- quality management software
- validated document control

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Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/2d9532e8-4af6-4897-a1eb-b84cc5a5af66?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)