Hims & Hers
Healthcare
QualitySystemsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Systems Specialist at Hims & Hers. Skills: Quality systems, Batch records, Regulatory compliance, Documentation review. Manage batch record issuance. Review executed batch records”
What You'll Achieve.
Ensure compliance with USP standards; Ensure compliance with GDP requirements; Ensure compliance with internal SOPs; Safeguard patient safety; Ensure alignment with regulatory requirements; Ensure alignment with business needs; Support audit readiness; Ensure timely investigation; Ensure timely resolution; Identify patterns; Identify continuous improvement opportunities
Industry & Context.
Deviation investigation; OOS investigation; Discrepancy investigation; Root cause analysis
What They're Looking For.
Must Have
3+ years related experience, Excellent attention to detail, Excellent documentation practices, Excellent organizational skills, Experience with investigations, Experience with deviation management, Experience with escalation procedures, Proficiency in Google Workspace
Nice to Have
Bachelor's degree preferred, Understanding of USP standards, Understanding of FDA 21 CFR Parts 210 & 211, Understanding of cGMP practices, Understanding of GDP practices, Understanding of GLP practices, Familiarity with quality systems software
What You'll Do.
Manage batch record issuance
Review executed batch records
Review associated records
Archive site documents
Audit documentation for compliance
Support quality system tool design
Support quality system workflow enhancement
Ensure timely archival
Participate in escalation
Participate in investigation
Participate in closure of deviations
Participate in closure of OOS results
Participate in closure of discrepancies
Collaborate with Compounding
Collaborate with Pharmacy
Collaborate with Quality Control
Collaborate with Inventory
Provide reports to management
Provide trending data
Provide metrics to management
Support internal audits
Support external audits
Draft work instructions
Revise work instructions
How You'll Work.
Team & Collaboration
Collaborate with Compounding; Collaborate with Pharmacy; Collaborate with Quality Control; Collaborate with Inventory
Full Job Description
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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE We are seeking a Quality Systems Specialist to join our Quality Unit. 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 , 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, Leg
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