Quality Specialist

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.

Key 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.

You Have:

• 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.

• Experience in a 503B outsourcing facility strongly preferred.

• 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.

Our Benefits (there are more but here are some highlights):

• Comprehensive health benefits including medical, dental & vision

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. 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. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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