hims & hers

1 week ago

Quality Control Manager, Sterile

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

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

Glassdoor: 2.9

Website LinkedIn Glassdoor

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hims & hers

1 week ago

Quality Control Manager, Sterile

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

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

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

Glassdoor: 2.9

Website LinkedIn Glassdoor