HH
$70,000 – $85,000
Listed on Hims and Hers’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
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. The full posting is on their site.
Skills this role names
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Visio
- Microsoft Word
- Risk Assessment
- Root Cause Analysis
- Statistical Analysis
Log in to see which of these are already on your profile.
What they ask for
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