Quality Control Manager, Sterile

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.About the Role: The Quality Control (QC) Manager is responsible for overseeing and executing all QC shop floor activities to ensure compounded sterile preparations (CSPs) meet established quality, safety, and regulatory standards. This role ensures compliance with USP <795>, USP <797>, USP <800>, state board requirements, and FDA guidance applicable to 503A sterile compounding environments. The QC Manager works closely with the Pharmacist in Charge, Quality Assurance, Microbiology, Compounding Operations, and Pharmacy leadership to maintain a robust quality control program that protects patient safety and supports continuous improvement.You Will:Product Testing & ReleaseOversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable.Manage coordination with third-party analytical laboratories, including sample submission, data review, and investigation of test abnormalities.Review and approve Certificates of Analysis (COAs) and ensure results meet specifications prior to product release.Environmental & Process MonitoringManage quality control shop floor activities during compounding operations to ensure appropriate coverage over all shifts.Ensure the quality control team remains compliant with gowning, line clearance, and visual inspection competency assessments and qualifications, along with other required training.Provide guidance to quality control team on room clearance, line clearance and Acceptable Quality Level (AQL) inspectionsIn collaboration with Microbiology, supervise viable and non-viable environmental monitoring in ISO-classified areas in accordance with USP <797>.Oversee personnel monitoring (gloves, gowns, fingertip sampling) and ensure compliance with established frequency and limits.Trend environmental monitoring data and implement corrective actions for excursions.Deviation, OOS, and Investigation ManagementCollaborate with Microbiology and Pharmacist in Charge on investigations for out-of-specification (OOS) results, sterility failures, and environmental excursionsConduct and document event investigations and root-cause analyses; propose and verify effectiveness of corrective and preventive actions (CAPA).Ensure investigations are timely, compliant, and thorough prior to seeking pharmacist approvalDocumentation & Record ControlEnsure quality batch record review checklists are completed in accordance with internal processes and procedures.Maintain accurate quality records, logs, test results, and retain sample documentation.Ensure data integrity principles (ALCOA+) are followed across all QC-related records.Support revision and creation of SOPs and work instructions related to QC operations.Equipment OversightCollaborate with the microbiology manager on qualification, calibration, and maintenance of QC instruments (e.g., particle counters, incubators, pH meters, balances).Ensure appropriate compounding equipment logs, preventive maintenance, cleaning and calibration files are maintained and up-to-date.Quality Systems SupportPartner with th ... (truncated, view full listing at source)