Specialist, Quality Control Operations

Overview

Hims & Hers Health, Inc. (better known as Hims & Hers) is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We are revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space.

Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS”. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below.

Hims & Hers is seeking an experienced Quality Control Operations Specialist to join our Quality Unit located in Gilbert, AZ. The position focuses on driving continuous improvement efforts that benefit and delight the Hims customer. The role reports to the Senior Manager Quality Operations. The Quality Control Operations Specialist is responsible for inspecting and/or testing products before, during, and after manufacturing processes to ensure products align with company and regulatory standards, as well as other processes necessary to quality operations.

The position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, USP, SOPs, and where applicable cGMP.

Day Shift: In the Gilbert, AZ facility

Monday-Friday: 6:30am-4:00pm PST. You must be flexible and open to being scheduled between 6:30am-4:00pm PST. The 8 hour shift you're scheduled depends on production needs.

Night Shift: In the Gilbert, AZ facility

5:00pm-4:00am PST

• 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 and 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:
  Implement procedures of sampling and guidelines for collection, testing, and reporting quality data
• Assist with drafting SOPs to follow internal policies, USP and other applicable regulatory guidelines
• Ensure compliance with USP , , and cleaning standards
• Assist in audit activities with all appropriate third party audits and internal audits as required to ensure compliance.

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred, plus 1-2 years experience in quality assurance/control, process engineering, and/or product formulation
• Working knowledge of USP-NF standards , , including monographs
• Experience in cGMP or regulated environment with knowledge of FDA 21 CFR 820 a plus
• Excellent interpersonal and communication skills (verbal and written)
• Solid understanding of product testing including best practices for testing product against defined specifications
• 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.
• Working knowledge and application of statistical analysis including probability and trend analysis
• Knowledge…