Quality Systems Specialist

Location

Gilbert, Arizona

Full time

On-site

QUALITY

• $30 – $40 per hour

Outlined above is a reasonable estimate of H&H’s compensation range for this role for US-based candidates
. If you're based outside of the US, your recruiter will be able to provide you with an estimated salary range for your location. The actual amount will take into account a range of factors that are considered in making compensation decisions, including but not limited to skill sets, experience and training, licensure and certifications, and location. H&H also offers a comprehensive Total Rewards package that may include an equity grant.

Consult with your Recruiter during any potential screening to determine a more targeted range based on location and job-related factors.

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  and  . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit

We are seeking a Quality Systems Specialist to join our Quality Unit in XeCare Pharmacy. This position plays a critical role in ensuring that all compounded products meet company and regulatory standards before release. The role has a heavy emphasis on documentation surrounding batch issuance, review, filing, and escalation of events
, and will support the QS Manager in daily operations. The QS Specialist is responsible for ensuring compliance with USP standards, Good Documentation Practices (GDP) requirements, and internal SOPs while safeguarding patient safety.

• Manage batch record issuance of compounded lots.
• Perform detailed review of executed batch records
  , associated records and test results to ensure accuracy, completeness, and compliance with USP , USP , USP and internal procedures. This practice will also include the scanning, filing, and archiving of site documents in both digital and physical systems.
• Audit documentation for compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available)
• Support the design and enhancement of quality system tools and workflows, ensuring alignment with regulatory requirements and business needs.
• Ensure timely filing and archival of batch-related documentation to support audit readiness.
• Participate in the escalation, investigation, and closure of deviations, OOS (out-of-specification) results, and discrepancies
  , ensuring timely investigation and resolution.
• Collaborate with Compounding, Pharmacy, Quality Control, and Inventory teams to ensure consistent batch activities have been documented and completed.
• Provide reports, trending data, and metrics to QS management to identify patterns and continuous improvement opportunities.
• Support internal and external audits by providing documentation and evidence related to raw material and component discrepancies and lot disposition.
• Participate in drafting and revising SOPs, work instructions, and protocols relating to quality system activities.
• Label Issuance*

• Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience.
• 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
• Strong understanding of USP , , standards, FDA 21 CFR Parts 210 & 211, and cGMP, GDP and GLP practices preferred.
• Excellent attention to detail, documentation practices, and organizational skills.
• Experience…