Quality Control Specialist
Hims & Hers· QUALITY
Gilbert, ArizonaFull-timePosted 1w ago
About the role
Quality Control Operations Specialist responsible for inspecting and testing products throughout manufacturing to ensure compliance with company, regulatory, and cGMP standards. Leads on-the-floor quality activities, dispositioning product and raw materials, and supports QA documentation, investigations, audits, and training.
Responsibilities
- Perform in process and post production quality checks, including testing, assessing and dispositioning products in the production suites (“shop floor”) to ensure product acceptability.
- Provide reports and trending data to QA management; support departments in reporting, handling and escalation of investigations
- Support external manufacturer non-conformance investigations to improve Hims Quality processes.
- Manage Hims Product Retains and inspections; support change control system to provide improvement solutions; support quality processes in the pharmacy – including testing inspections, verification of pH meters and scales, non-conformance/deviation/complaint investigations, implement corrective action activities, training activities, etc.
- Document & review of records: SOP generation, batch record review, COA acceptance, USP monographs, etc.
- Detect training needs, provide reports to Site Manager to ensure compliance with quality standards
- Assist with incoming raw material inspections: sampling procedures, testing, and reporting quality data
- Assist with drafting SOPs and protocols to follow internal policies, USP and other applicable regulatory guidelines; ensure compliance with USP <795> and cGMP cleaning standards
- Assist in audit activities with all appropriate third party audits & internal audits as required to ensure compliance.
- Assist with the management and reporting of samples to be tested with contract laboratories.
Qualifications
- B.S. in chemistry, biology, quality management, engineering, or related discipline preferred.
- 2+ years experience in quality assurance/control, process engineering, and/or product formulation
- Experience within a 503b outsourcing facility; Aseptic processing experience; knowledge of ISO 14644; working knowledge of USP-NF standards <795>, <797>, <800>; familiarity with cGMP and FDA 21 CFR 210, 211 a plus
- Excellent interpersonal and communication skills (verbal and written)
- Solid understanding of product testing and ability to test against defined specifications
- Ability to multi-task and work independently; highly motivated self-starter
- Strong computer skills (Word, Excel, Visio, PowerPoint, Outlook); experience with MRP; decision making, data collection/analysis, organizing and planning
- Knowledge of statistical analysis, technical writing, auditing
- Some travel may be required
Skills
Required:Quality Assurance & ControlRegulatory Compliance (USP, cGMP, FDA 21 CFR)Documentation & SOP Writing
Benefits
- A dynamic, open & honest culture of collaborative co-workers where diverse perspectives are welcome & valued
- Competitive pay with equity compensation
- ESPP Plan
- Flexible PTO
- Holidays observances
- Quarterly Mental Health Days
- High-coverage medical, dental & vision (FSA & HSA plan options)
- Pet Insurance
- One Medical Membership
- Disability Benefits
- Employee Assistance Program
- Life and AD&D Benefits
- Fitness stipend
- Backup childcare
- Family forming resources
Last updated Oct 14, 2026. Interested? Apply on the company site.
About Hims & Hers
More open roles at Hims & Hers
- Quality Assurance Investigations Specialist5d agoMesa, Arizona, Gilbert, Arizona · QUALITY
- Environmental Monitoring (EM) Specialist5d agoNew Albany, Ohio · QUALITY
- Quality Control Specialist, Sterile (Nights)5d agoNew Albany, Ohio · QUALITY
- Quality Control Specialist, Sterile (Nights)5d agoNew Albany, Ohio · QUALITY
- Quality Systems Document Control Specialist5d agoGilbert, Arizona, Mesa, Arizona · QUALITY