Hims & Hers

Healthcare

QualitySystemsSpecialist

$0–0k New Albany, Ohio, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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

Free ATS check

Applying for this Quality Systems Specialist role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Ashby

  • Ashby is a fast modern ATS — most applications take under 3 minutes.
  • The resume parser is strong; verify parsed experience dates and job titles.
  • Custom screening questions are often scored algorithmically — answer completely.
  • Location field affects geo-based screening; use your actual metro area.

ANONYMOUS · UNFILTERED

What do employees actually say about Hims & Hers?

Real rants from real employees. Read before you apply.

Read Company Rants →