Quality Control Specialist

The role

The Quality Control Specialist inspects and tests products before, during, and after manufacturing to ensure compliance with company and regulatory standards. This role performs activities on the shop floor to support product and raw material dispositioning.

What you will do

• Perform in process and post production quality checks
• Provide reports and trending data to QA management
• Support external manufacturer non-conformance investigations
• Manage Hims Product Retains and inspections
• Support change control system
• Support quality processes in the pharmacy
• Document and review records including SOP generation and batch record review
• Detect training needs and provide reports to Site Manager
• Assist with incoming raw material inspections
• Assist with drafting SOPs and protocols

Required qualifications

• 2+ years experience in the area of 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, including monographs
• Excellent interpersonal skills and communication skills (verbal and written)
• Solid understanding of product testing
• Ability to multi-task and work independently
• Highly motivated self-starter
• Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook
• MRP
• Excellent skills in decision making, data collection and analysis, organizing and planning

Nice to have

• B.S. in chemistry, biology, quality management, engineering, or related discipline
• Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211

Benefits

• 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

About the company

Hims & Hers is a health and wellness platform that provides access to personalized care. It is a public company traded on the NYSE.