Hims AND Hers

Hims AND Hers

Quality Specialist

Los Alamitos, California · Full-time

Sponsorship not specifiedDetected 8 days ago
ExcelGMPFDA RegulatoryCommunicationWritingMicrosoft Office

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.

Responsibilities

  • 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.
  • 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.
  • 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.
  • Support risk management and assessment activities for assigned areas.
  • Participate in internal and external (third-party and regulatory) audits and help maintain continuous inspection readiness.
  • No two people are the same, so we provide access to personalized care designed for results.

Nice to have

  • 2+ years of experience in Quality Assurance and/or Quality Control within an FDA-regulated environment
  • sterile injectable cGMP or 503B outsourcing facility experience strongly preferred.
  • Working knowledge of FDA cGMP (21 CFR Parts 210, 211, and 11) and Section 503B of the FD&C Act.
  • Working knowledge of USP-NF standards - including <795>, <797>, and <800> - and applicable monographs.
  • Aseptic processing experience and familiarity with ISO 14644, contamination control, and sterility-assurance principles.
  • Hands-on experience with batch record review, in-process and finished-product inspection, and product disposition against defined specifications.
  • Experience with core quality system elements - deviations/CAPA, change control, document control, and investigations - within paper and/or electronic QMS (e.g., TrackWise).
  • Experience supporting internal and regulatory (e.g., FDA) audits and inspections.

Compensation

  • Support preparation of the Annual Product Quality Review (APQR) through data compilation and trending.
  • Competitive salary & equity compensation for full-time roles

Benefits

  • 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
  • We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.
  • Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
  • 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.

Equal opportunity

  • If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation.
  • Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation.
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This listing is sourced directly from Hims AND Hers's careers page and normalized into a canonical job model.