hims & hers · 1 day ago
Quality Systems Specialist
United States
Full-time
Remote
Mid Level
$30/hr - $40/hr
3+ years expHims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. They are seeking a Quality Systems Specialist to ensure that all compounded products meet company and regulatory standards before release, with an emphasis on documentation and compliance.
Health CareLifestyleMen'sWellnessWomen's
Responsibilities
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
Qualification
Required
Bachelor's degree 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
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)
Company
hims & hers
Hims is a wellness brand that helps men and women get access to products for skin care, hair loss, and sexual health.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Franklin TempletonIVPThrive Capital
2025-05-08Post Ipo Debt· $1B
2021-01-21Post Ipo Equity· $75M
2021-01-21IPO
Leadership Team
Andrew Dudum
Founder & CEO
Yemi Okupe
CFO
Recent News
dcm.com
2025-12-31
Company data provided by crunchbase