Quality Control Specialist, Sterile (Nights)

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 redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit located in New Albany, Ohio. 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 Manager. The Quality Specialist role is responsible for inspecting and/or testing of product(s) before, during, and after the 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.

• Perform in-process and post-production quality checks, including testing, assessing products in the compounding suites (“shop floor”) 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 Manager 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.

• B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred

• 2+ years of experience in the area of quality assurance/control, process/quality engineering, and/or product formulation

• A Pharmacy Technician license or willingness 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 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

• Ability to manage multiple tasks simultaneously, with strong time management and organizational skills.

• Excellent interpersonal skills, communication skills, and technical writing

• Solid understanding of product testing, including understanding best practices for testing product against defined specifications

• Ability to multitask and work independently. Highly motivated self-starter.

• 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 documentation and facility auditing

• Some travel may be required