Quality Specialist

Hims & Hers • Los Alamitos, CA

8d • Onsite

About The Position

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: Hims & Hers is seeking a Quality Specialist (Contract – 2–3 Months) to join our Quality Unit in Los Alamitos, CA. This is a short-term, high-impact role designed for a quality professional with a broad skillset who can provide immediate support across Quality Assurance, Quality Control, Document Control, Training, and Validation functions. This position reports to the Quality Assurance Manager and plays a hands-on role both supporting production and within the Quality Management System (QMS). The ideal candidate is comfortable operating in a fast-paced cGMP facility and can independently manage investigations, documentation, compliance activities, and cross-functional coordination while ensuring adherence to cGMP and other applicable regulations.

Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, Quality Management, or related discipline preferred.
• 2+ years of experience in Quality Assurance, Quality Control, or a regulated pharmaceutical/compounding environment.
• Working knowledge of USP <795>, <797>, <800>, ISO 14644, and cGMP regulations (FDA 21 CFR 210/211).
• Experience with investigations, batch record review, document control systems, and audit support.
• Strong technical writing skills (SOPs, reports, protocols).
• Proficiency with Microsoft Office and electronic quality/training systems (e.g., Trackwise, DMS, LMS/Docebo).
• Solid analytical skills, including data trending and basic statistical analysis.
• Highly organized, detail-oriented, and capable of working independently in a fast-paced environment.

Nice To Haves

• Experience in a 503B outsourcing facility strongly preferred.

Responsibilities

• Quality Assurance Lead and support quality event investigations (Deviations, OOS) and maintain accurate logs and trackers.
• Own and manage Change Controls and support Document Change Control (DCC) activities.
• Conduct batch record review (including R&D batches), create and maintain batch record folders, and review COAs and supporting documentation.
• Prepare summary reports (e.g., stability reports) and provide trending data to QA management.
• Follow up on vendor qualifications and support supplier quality activities.
• Ensure compliance with USP <795>, <797>, <800>, FDA 21 CFR 210/211, ISO 14644, and applicable cGMP standards.
• Support internal and external audit readiness and contract laboratory coordination.
• Quality Control Perform incoming and receiving inspections, including sampling coordination and documentation.
• Support Environmental Monitoring (EM) activities, including data entry, trending, and plate reading.
• Track and trend test data to ensure products meet defined specifications.
• Provide quality support to manufacturing and pharmacy operations.
• Assist with SOP development and revisions related to QC activities.
• Document Control & Training Support scanning, archiving, indexing, and organization of electronic and physical quality records to ensure audit readiness.
• Upload revised SOPs and training materials into learning management system (Docebo); archive obsolete documents in accordance with retention requirements.
• Support employee training including tracking, follow-up, administration and grading of quizzes, and escalation of competency gaps.
• Maintain accurate logs and trackers for quality events, EM data, training records, and controlled documents.
• Support the Document Management System (DMS) implementation, including metadata entry, scanning, upload, routing, and archival workflows.
• Validation Support Assist with calibration tracking and scheduling.
• Provide documentation support for validation-related Change Controls and SOP updates.
• Support eQMS (Trackwise) and other validation testing, as required.

Benefits

• Comprehensive health benefits including medical, dental & vision

What This Job Offers

• Career Level: Mid Level