Quality Control Specialist

Quality Control Specialist

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit located in Gilbert, Arizona. 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 Quality Control Supervisor. 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 support quality operations. The position performs and leads activities in compounding suites 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 and batch disposition.

Night Shift Position: 5:30pm to 4:00am (Sun-Wed or Wed-Sat)

You Will:

• Perform in process and post production quality checks, including testing, assessing products in the compounding suites to ensure product acceptability.
• Perform line clearance, where applicable.
• Perform AQLs during the visual inspection process
• 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 Quality processes.
• Manage product retain samples.
• Support change control system to provide improvement solutions
• Support quality processes in the pharmacy – including inspections, pH meters and scale checks, 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.
• Recommend training needs, provide reports to QC Supervisor and Lead Pharmacist to ensure compliance with quality standards
• Assist with incoming raw material inspections, as needed per the guidelines for collection, testing, and reporting quality data.
• Assist with drafting SOPs and protocols to follow internal global policies, USP and other applicable regulatory guidelines
• Ensures compliance with USP <795>, USP <797>, USP <800> 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 of samples to be tested with contract laboratories.

You Have:

• B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline
• 1-3 years experience in the area of quality assurance/control, process/quality engineering, and/or product formulation
• A Pharmacy Technician license or ability to obtain one within the first six months of employment (we cover costs and will help you obtain your trainee hours).
• Experience within a 503b outsourcing facility or experience in cGMP (Current Good Manufacturing Practice) or regulated environment with knowledge of FDA 21CFR 210 and 211, a plus
• Aseptic processing experience and knowledge of ISO 14644
• Working knowledge of USP-NF standards <795>, <797>, <800> including monographs
• Excellent interpersonal skills, communication skills and technical writing
• Solid understanding of product testing including understanding best practices for testing product against defined specifications
• Solid computer skills with Word, Excel, PowerPoint, and Google platform applications.
• 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 good documentation practice and facility auditing
• Overall willingness to learn, work, and assist/train in any pharmacy related tasks and are able to adapt to fast-changing conditions
• 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)
• 401k benefits with employer matching contribution
• Offsite team retreats

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.