Batch Review 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
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.
You Will
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 <795>, USP <797>, USP <800> 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*
You Have
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 <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP, GDP and GLP practices preferred.
Excellent attention to detail, documentation practices, and organizational skills.
Experience with investigations, deviation management, and escalation procedures.
Proficiency in Google Workspace and familiarity with quality systems software.
Strong interpersonal and communication skills (written and verbal).
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.
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