# Quality Specialist

Hiring organization: [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers)

Canonical page: https://career.thegoodapps.co/jobs/ee57062d-31ac-4f6d-9ca3-fe0bf598c31e

Listed on Hims and Hers's own careers site. Applications go to them directly.

- Employment type: full time
- Location: Los Alamitos, CA
- Salary: 70000 – 85000 USD per year

## Summary

This role oversees quality compliance and product integrity in a sterile pharmaceutical manufacturing environment, ensuring medications meet FDA and USP standards before release. It suits someone with hands-on quality assurance experience in regulated drug manufacturing who is comfortable with regulatory detail and floor-level oversight.

_Our summary, not Hims and Hers's wording._

## Skills named

Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Microsoft Word, Risk Assessment, Root Cause Analysis, Statistical Analysis

## Required

- 2+ years of quality assurance or quality control experience in FDA-regulated environments
- Working knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, 11) and Section 503B of the FD&C Act
- Working knowledge of USP-NF standards including <795>, <797>, <800>
- Aseptic processing experience and familiarity with contamination control and sterility assurance
- Hands-on experience with batch record review and product disposition
- Experience with deviations, CAPA, change control, document control, and investigations
- Experience supporting internal and regulatory audits
- Root cause analysis and trend analysis skills
- Strong technical writing and communication skills

## Nice to have

- Sterile injectable cGMP or 503B outsourcing facility experience
- Familiarity with electronic quality management systems like TrackWise
- Statistical and trend analysis background

Apply on Hims and Hers's site: https://jobs.ashbyhq.com/hims-and-hers/3f295f0f-5d54-4c05-9b1b-657451519f02/application