Quality Specialist
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Job Location:
Los Alamitos, CA - USA
Hourly Salary:
$ 33 - 38
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: Hims & Hers is seeking a Quality Specialist (Contract 23 Months) to join our Quality Unit on site at our facility 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: 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. 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. 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. 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: Bachelors 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. 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 youre excited about this role we encourage you to applyeven if youre 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 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. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: ICQuality Assurance
Quality Control
Document Control & Training
Validation Support
Our Benefits (there are more but here are some highlights):
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
