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.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 lity 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) inspectionservise 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.Maintas, 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 the Pharmacist k inspections, and regulatory inspections.Participate nge controls, and continuous improvement meetings.Support training of pharmacy staff on quality compliance requirements and aseptic principles.Operational SupportProvide technical and shop floor support to sterile compounding personnel related to testing requirements, sampling, and product specifications.Ensure proper handling, storage, and disposal of testing materials, media, and reagents.Monitor trends to identify opportunities to enhance sterility assurance and product quality.You Have:Bachelor’s degree robiology, Biology, Pharmaceutical Sciences, or related field.Minimum 3–5 years of QC experience in a sterile compounding, pharmaceutical, or biotech environment.Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP, and state pharmacy regulations.Experience with laboratory investigations, root-cause analysis, and CAPA processes.Demonstrated ability to interpret analytical data and laboratory test results.Excellent documentation skills and attention to detail.Preferred QualificationsExperience working directly in a 503A compounding pharmacy or 503B outsourcing facility.Familiarity with FDA guidance on sterile compounding.Supervisory experience or the ability to lead and develop QC staff.Experience with LIMS or electronic quality systems.Core CompetenciesQuality-focused decision-makingStrong problem-solving and analytical abilityAseptic knowledge and high attention to detailEffective communication and collaboration across pharmacy and quality teamsAbility to manage multiple priorities in a fast-paced, regulated environmentOur Benefits (there are more but here are some highlights):Competitive salary & equity compensation for full-time rolesUnlimited PTO and company holidaysComprehensive health benefits including medical, dental & vision, and parental leaveEmployee Stock Purchase Program (ESPP)401k benefits with employer matching contributionConditions 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 luding 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.
