Quality Control Manager, Sterile

hims & hers
United States
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 3-5 yearsEducation: bachelorsSkills: ["Quality-focused decision-making","Strong problem-solving","Analytical ability","Aseptic knowledge","Attention to detail"]

Oversee and execute sterile compounding quality control shop floor activities to ensure compounded sterile preparations meet required quality, safety, and regulatory standards. Manage sampling, sterility/endotoxin/potency/identity testing, COA review, environmental and personnel monitoring in ISO-classified areas, and investigations for OOS, sterility failures, and excursions. Ensure documentation and data integrity (ALCOA+), equipment qualification/maintenance, SOP support, and audit readiness across the QC and pharmacy teams.

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FursaFursa
hims & hers
hims & hers
2 months 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: 13 hours agoStatus: Live
Reposted: similar role first listed 8 months ago

Job Summary

Oversee and execute sterile compounding quality control shop floor activities to ensure compounded sterile preparations meet required quality, safety, and regulatory standards. Manage sampling, sterility/endotoxin/potency/identity testing, COA review, environmental and personnel monitoring in ISO-classified areas, and investigations for OOS, sterility failures, and excursions. Ensure documentation and data integrity (ALCOA+), equipment qualification/maintenance, SOP support, and audit readiness across the QC and pharmacy teams.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Oversee sampling, testing, and documentation of sterile drug products (sterility, endotoxin, potency, identity, particulate matter, and pH as applicable).
  • •Coordinate with third-party analytical laboratories; review data, investigate abnormalities, and approve Certificates of Analysis (COAs) before product release.
  • •Manage environmental and personnel monitoring during compounding, including gowning/line clearance/visual inspection competency and ISO-classified monitoring per USP <797>.
  • •Lead investigations for out-of-specification (OOS) results, sterility failures, and environmental excursions; conduct root-cause analysis and ensure timely, compliant CAPA.
  • •Maintain QC documentation and records, support SOP/work instruction revisions, and partner on audits, risk assessments, and regulatory inspections.

Pay and Benefits

Perks:Health InsuranceDentalVisionPaid LeaveParental Leave401kEspp

Key Requirements

  • •Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or related field.
  • •Minimum 3–5 years of QC experience in a sterile compounding, pharmaceutical, or biotech environment.
  • •Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP, and state pharmacy regulations.
  • •Experience conducting laboratory investigations, root-cause analysis, and CAPA processes.
  • •Excellent documentation skills and ability to interpret analytical data and laboratory test results.
Experience:3-5 yearsSterile compoundingPharmaceuticalsBiotech
Education:Bachelor's in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or related field
Skills:Quality-focused decision-makingStrong problem-solvingAnalytical abilityAseptic knowledgeAttention to detail
Tech Stack:LIMSISO 797ALCOA+SOPsCAPA

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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