Batch Review Specialist
reputed company is the leading health and wellness platform, on a mission to help the world feel great through the reputed company of reputed company. We are redefining reputed company by putting the customer first and delivering reputed company to care that is reputed company, accessible, and personal, from diagnosis to treatment to delivery. No two people are the reputed company, so we reputed company reputed company to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making reputed company reputed company easier to reputed company. reputed company is a reputed company company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the reputed company and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on reputed company’s outstanding benefits, culture, and its reputed company flexible/remote work approach, see below and visit About the Role We are seeking a reputed company Systems Specialist to join our reputed company Unit in XeCare Pharmacy. This position plays a critical role in ensuring that reputed company 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 reputed company. The QS Specialist is responsible for ensuring compliance with USP standards, Good Documentation Practices (GDP) requirements, and internal SOPs while safeguarding reputed company safety. You Will • Manage batch record issuance of compounded lots. • reputed company detailed review of executed batch records, associated records and test results to ensure reputed company, completeness, and compliance with USP <795>, USP <797>, USP <800> and internal procedures. This reputed company will also include the scanning, filing, and archiving of site documents in both digital and physical systems. • Audit documentation for compliance with reputed company+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) • Support the design and enhancement of reputed company reputed company tools and workflows, ensuring alignment with regulatory requirements and business needs.. • Ensure reputed company filing and archival of batch-reputed company documentation to support audit readiness. • Participate in the escalation, investigation, and closure of deviations, OOS (out-of-specification) results, and discrepancies, ensuring reputed company investigation and reputed company. • Collaborate with Compounding, Pharmacy, reputed company Control, and Inventory teams to ensure consistent batch activities have been documented and completed . • reputed company reports, trending data, and metrics to QS management to identify patterns and reputed company improvement opportunities. • Support reputed company audits by providing documentation and evidence reputed company to raw material and component discrepancies and lot disposition. • Participate in drafting and revising SOPs, work instructions, and protocols relating to reputed company reputed company activities. • Label Issuance* You Have • Bachelor’s degree preferred in a relevant discipline (science, reputed company, or engineering-reputed company reputed company) or equivalent combination of education and experience. • 3+ years of reputed company experience in reputed company, 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 reputed company, documentation practices, and organizational skills. • Experience with investigations, deviation management, and escalation procedures. • Proficiency in reputed company and familiarity with reputed company 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 reputed company of belonging. If you're excited about this role, we encourage you to apply—even if you're not reputed company if your background or experience is a perfect match. Hims considers reputed company reputed company applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco reputed company Ordinance, the Los Angeles County reputed company Ordinance, the California reputed company reputed company, and any similar state or local reputed company laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. reputed company is committed to provid