Quality Specialist

​​About the Role:

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit located in Los Alamitos, CA. The position of Quality Specialist will focus on driving continuous improvement efforts that benefit and delight the Hims customer.  We are looking for a highly motivated individual to help support and report to the Director of  Quality.  The Quality Specialist role is responsible for the inspecting and/or testing of product(s) before, during and after manufacturing process(es) 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. Assist with relevant environmental monitoring programs.

You Will:

• 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: Implement procedures of sampling (where applicable) and guidelines for collection, testing, and reporting quality data
• Assist with drafting SOPs and protocols to follow internal policies, USP and other applicable regulatory guidelines
• Ensures 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.

You Have:

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred 
• 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 and knowledge of ISO 14644
• Working knowledge of USP-NF standards <795>, <797>, <800> including monographs 
• Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211 a plus
• Excellent interpersonal skills and communication skills (verbal and written)
• Solid understanding of product testing including understanding 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 and experience in technical writing
• Knowledge and experience in Auditing
• Some travel may be required

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats

Conditions of Employment: 

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.