Quality Control Specialist

Location: New Albany, Ohio, United States; on-site. Night shift: 6:00pm–6:30am on a 3-2-2-3 schedule.

Company

Hims & Hers is a public health and wellness platform providing personalized care from diagnosis through treatment and delivery.

What you will do

• Perform in-process and post-production inspections and testing in compounding suites, including line clearance and AQL visual inspections.
• Support product and raw-material disposition, retain sample management, environmental monitoring, and contract laboratory sample coordination.
• Report quality data and trends, support investigations and non-conformance escalations, and assist with corrective actions and change controls.
• Review batch records, certificates of analysis, SOPs, protocols, USP monographs, and other quality documentation.
• Support pharmacy quality processes, audits, training, and compliance with USP, cGMP, and internal policies.
• Assist with external manufacturer investigations and continuous improvement of quality operations.

Requirements

• Bachelor’s degree in chemistry, microbiology, biology, quality management, engineering, or a related discipline preferred.
• At least 2 years of experience in quality assurance/control, process or quality engineering, or product formulation.
• Pharmacy Technician license, or willingness to obtain one within the first six months; associated costs and trainee hours are covered.
• Experience with product testing, statistical and trend analysis, documentation, auditing, and quality data collection.
• Knowledge of aseptic processing, ISO 14644, USP-NF standards <795>, <797>, and <800>, and applicable cGMP requirements.
• Ability to work independently, manage multiple tasks, communicate effectively, write technical documentation, and use Microsoft Office and Google applications.

Nice to have

• Experience in a 503b outsourcing facility or another FDA-regulated environment.
• Knowledge of FDA 21 CFR 210 and 211.
• Some travel availability.

Culture & Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited paid time off, company holidays, and quarterly mental health days.
• Medical, dental, and vision coverage, plus parental leave.
• Employee Stock Purchase Program and 401(k) with employer matching.
• Work involves hazardous drugs and requires PPE, respiratory-protection medical approval, physical exertion, and lifting up to 50 pounds.