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hims & hers

Connects patients to online medical care

Quality Control Specialist

Inspection & TestConfirmed live in the last 24 hours
Full-timeGilbert, AZ, USANo salary listed

About the Job

Requirements

  • At least 2 years of experience in quality assurance or control, process engineering, and/or product formulation.
  • Experience within a 503b outsourcing facility and aseptic processing experience, with knowledge of ISO 14644.
  • Working knowledge of USP-NF standards <795>, <797>, and <800>, including monographs.
  • Experience in a cGMP or regulated environment, with knowledge of FDA 21 CFR 210 and 211.
  • A solid understanding of product testing and best practices for testing products against defined specifications.
  • Ability to multitask and work independently.
  • Computer skills with Word, Excel, Visio, PowerPoint, Outlook, and MRP.
  • Skills in decision-making, data collection and analysis, organizing, and planning.
  • Working knowledge and application of statistical analysis, including probability and trend analysis.
  • Knowledge and experience in technical writing and auditing.

Responsibilities

  • Perform in-process and post-production quality checks, including testing, assessing, and dispositioning products in production suites to ensure product acceptability.
  • Provide reports and trending data to Quality Assurance management, and support departments in reporting, handling, and escalating investigations.
  • Support external manufacturer non-conformance investigations to improve Hims Quality processes.
  • Manage Hims product retains and inspections, and support the change control system by providing improvement solutions.
  • Support pharmacy quality processes, including testing inspections, verification of pH meters and scales, non-conformance, deviation, and complaint investigations, corrective action activities, and training activities.
  • Document and review records, including generating standard operating procedures, reviewing batch records, accepting certificates of analysis, and handling USP monographs.
  • Identify training needs and provide reports to the Site Manager to ensure compliance with quality standards.
  • Assist with incoming raw material inspections, including implementing sampling procedures where applicable and guidelines for collecting, testing, and reporting quality data.
  • Assist with drafting standard operating procedures and protocols that follow internal policies, USP, and applicable regulatory guidelines.
  • Ensure compliance with USP <795> and cGMP cleaning standards.
  • Assist with third-party and internal audit activities as required to ensure compliance.
  • Assist with management and reporting of samples to be tested by contract laboratories.

Desired Qualifications

  • A B.S. in chemistry, biology, quality management, engineering, or a related discipline is preferred.
  • Knowledge of FDA 21 CFR 210 and 211 is a plus.
  • Some travel may be required.

About the Company

hims & hers

Connects patients to online medical care

Hims & Hers operates a consumer health platform that connects people with licensed providers for online consultations and ongoing care. Its Hims and Hers brands give customers access to services for hair loss, sexual health, mental health, skin care, and weight management, alongside prescription and nonprescription products. Providers assess patients and make treatment decisions, while the group coordinates digital records, follow-up, and fulfillment through owned and partner pharmacies. Revenue comes from product sales and subscriptions that combine recurring shipments with access to care. Hims & Hers was founded in 2017 and is headquartered in San Francisco, California.

Company size
1,001-5,000
Company stage
Post IPO Equity
Headquarters
San Francisco, California
Founded
2017

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