Quality Systems Specialist
Job Location:
New Albany, OH - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 were 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 companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit 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. 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. Bachelors 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 youre excited about this role we encourage you to applyeven if youre 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. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: IC
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
