Hims & Hers
Quality Control Specialist, Sterile (Nights)
New Albany, Ohio · On-site · Full-time · Posted Oct 14, 2026
- Experience
- 2+ years in quality assurance/control, process/quality engineering, and/or product formulation.
- Education
- Bachelor’s degree in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred.
About the job
Performs quality inspections, testing, documentation, and compliance activities for sterile pharmacy manufacturing on the night shift.
What you'll do
- Conduct in-process and post-production checks, including product testing, visual inspection AQLs, and line clearance where applicable.
- Support investigations, change control, audits, environmental monitoring, and quality reporting and trend analysis.
- Review quality records and assist with SOPs, raw-material inspections, retain samples, and compliance with applicable USP standards and cGMP.
What they ask for
- 2+ years of experience in quality assurance/control, process/quality engineering, and/or product formulation.
- Pharmacy Technician license or willingness to obtain one within the first six months of employment.
- Aseptic processing experience and knowledge of ISO 14644.
- Working knowledge of USP-NF standards <795>, <797>, and <800>, including monographs.
Nice to have
- Bachelor’s degree in chemistry, microbiology, biology, quality management, engineering, or a related discipline.
- Experience in a 503b outsourcing facility or cGMP/regulated environment with knowledge of FDA 21CFR 210 and 211.
Tools
USP-NF, ISO 14644, FDA 21CFR 210 and 211, cGMP, Word, Excel, PowerPoint, Google platform applications
Model-written summary · the original posting is authoritative