Quality Control Manager, Sterile

hims & hers
United States
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 3+ yearsEducation: bachelorsSkills: ["Leadership","Mentoring","Communication","Attention to detail","Cross-functional collaboration"]

Lead quality control for a large-scale sterile compounding pharmacy in New Albany, overseeing in-process and post-production inspections, testing, and product disposition. Drive continuous improvement by managing deviations and non-conformances, performing root cause analysis and corrective actions, and maintaining the product retain program. Ensure compliance with USP standards, cGMP practices, SOPs, and regulatory requirements, while supporting audits, external testing, and staff training and mentorship.

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FursaFursa
hims & hers
hims & hers
2 days ago

Quality Control Manager, Sterile

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 9 hours agoStatus: Live
Reposted: similar role first listed 7 months ago

Job Summary

Lead quality control for a large-scale sterile compounding pharmacy in New Albany, overseeing in-process and post-production inspections, testing, and product disposition. Drive continuous improvement by managing deviations and non-conformances, performing root cause analysis and corrective actions, and maintaining the product retain program. Ensure compliance with USP standards, cGMP practices, SOPs, and regulatory requirements, while supporting audits, external testing, and staff training and mentorship.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Lead and perform in-process and post-production quality checks, including product inspections, testing, and disposition across compounding stages.
  • •Manage day-to-day production floor quality to ensure product and raw material compliance, including oversight of critical equipment verifications and calibrations.
  • •Compile, analyze, and present trending data and quality reports to QA management.
  • •Oversee investigations for non-conformances, deviations, and customer complaints, driving root cause analysis and corrective actions.
  • •Review and approve compound records, Certificates of Analysis (COAs), and raw material documentation; draft and update SOPs and support audits and external testing.

Pay and Benefits

Perks:Health InsuranceDentalVisionPaid LeaveParental Leave401kEquityEspp

Key Requirements

  • •3+ years of experience in quality control or quality assurance in a sterile compounding or pharmaceutical manufacturing environment.
  • •Strong working knowledge of USP standards and applicable cGMP practices, ensuring protocols are followed.
  • •Experience in a regulated environment, including FDA 21 CFR 210/211 experience as a plus.
  • •Experience with environmental monitoring and ability to manage investigations, root cause analysis, and corrective actions.
  • •Must be able to lead and mentor quality and production personnel; strong technical writing skills for SOPs, protocols, and reports.
Experience:3+ yearsPharmaceutical manufacturingSterile compoundingRegulated environment
Education:Bachelor's in Chemistry, Biology, Pharmacy, Quality Management, Engineering, or related discipline
Skills:LeadershipMentoringCommunicationAttention to detailCross-functional collaboration
Tech Stack:USPCGMPFDA 21 CFR 210/211Environmental monitoringMicrosoft Office SuiteWordExcelPowerPointOutlookMRPSOPsCertificates of Analysis (COAs)Root cause analysisStatistical quality control

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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