Job Opportunities API

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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE: The Quality Specialist is an individual contributor within the site Quality Unit, supporting Quality activities in a sterile injectable cGMP / 503B environment. The role executes day-to-day quality oversight “on the floor” and within the Quality Management System (QMS) — including in-process and finished-product oversight, batch record review, environmental monitoring support, deviations and CAPA, change control, document control, and investigations — to ensure products meet identity, strength, quality, purity, and sterility-assurance requirements in alignment with 21 CFR Parts 210, 211, and 11, Section 503B of the FD&C Act, and USP standards. Working under the direction of QA management, the Quality Specialist supports release and disposition activities, identifies and escalates significant quality events, and helps sustain a state of continuous inspection readiness and a culture of compliance and continuous improvement. Key Responsibilities: - Provide in-process and finished-product quality oversight on the manufacturing floor, including monitoring of manufacturing and aseptic processing operations for compliance with approved procedures, cGMP, and USP standards. - Perform batch record review and support batch disposition, verifying that documentation, testing, and investigations are satisfactorily completed prior to release in accordance with approved procedures. - Review and provide input on procedures, specifications, master/executed batch records, and controlled forms to ensure accuracy, completeness, and regulatory compliance. - Support the environmental monitoring (EM) program, including review of data and prompt escalation of excursions and adverse trends. - Support packaging and labeling controls, including label issuance, reconciliation, and verification to prevent mix-ups and labeling errors. - Assist with incoming material inspection and material control — sampling, Certificate of Analysis (COA) review and acceptance, and disposition of components and raw materials. - Support vendor/supplier quality oversight and the management of contract-laboratory testing, including sample submission, tracking, and review of results. - Support document control and the SOP lifecycle — authoring, revision, routing, and periodic review of GMP documentation — and maintain a current, compliant, audit-ready repository. - Initiate, support, and document deviations, OOS, and CAPAs, including investigation, root cause analysis, and verification of effectiveness. - Support quality system programs including, change control, document control, training, complaints, quality event management, etc. and the implementation of Trackwise eQMS. - May serve as a process owner for an element of the quality system, based on experience and background. - Support risk management and assessment activities for assigned areas. - Participate in internal and external (third-party and regulatory) audits and help main