hims & hers

1 week ago

Quality Specialist

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Serve as an individual contributor in the site Quality Unit, providing day-to-day quality oversight in a sterile injectable cGMP/503B environment. You’ll conduct in-process and finished-product checks, review batch records, support environmental monitoring, manage deviations/OOS/CAPA and change/document controls, and help sustain continuous inspection readiness. The role includes supporting audits and release/disposition activities using QMS tools such as Trackwise.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Provide in-process and finished-product quality oversight on the manufacturing floor, including monitoring manufacturing and aseptic processing operations for compliance with approved procedures, cGMP, and USP standards.
•Perform batch record review and support batch disposition by verifying documentation, testing, and investigations are complete prior to release.
•Support environmental monitoring by reviewing data and escalating excursions and adverse trends.
•Initiate, support, and document deviations, OOS, and CAPAs, including investigation, root cause analysis, and effectiveness checks.
•Support document control and SOP lifecycle activities and participate in internal/external audits to maintain continuous inspection readiness.

Pay and Benefits

Salary: USD 70,000 - 85,000 annually

Perks:Health InsuranceDentalVisionParental LeavePaid Leave401kEquity

Key Requirements

•2+ years of experience in Quality Assurance and/or Quality Control within an FDA-regulated environment, with sterile injectable cGMP or 503B outsourcing facility experience strongly preferred.
•Working knowledge of FDA cGMP (21 CFR Parts 210, 211, and 11) and Section 503B of the FD&C Act.
•Working knowledge of USP-NF standards, including <795>, <797>, and <800>, and applicable monographs.
•Aseptic processing experience and familiarity with ISO 14644, contamination control, and sterility-assurance principles.
•Hands-on experience with batch record review, product disposition, and core quality system elements (deviations/CAPA, change control, document control, investigations) in paper and/or electronic QMS (e.g., Trackwise).

Experience:2+ yearsFDA-regulated

Skills:Technical writingCommunicationDocumentationIndependent workDetail-oriented

Tech Stack:TrackwiseQMSEQMS21 CFR Parts 21021 CFR Parts 21121 CFR Part 11503BUSP-NFISO 14644WordExcelVisioPowerPointOutlook

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 Specialist

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Provide in-process and finished-product quality oversight on the manufacturing floor, including monitoring manufacturing and aseptic processing operations for compliance with approved procedures, cGMP, and USP standards.
•Perform batch record review and support batch disposition by verifying documentation, testing, and investigations are complete prior to release.
•Support environmental monitoring by reviewing data and escalating excursions and adverse trends.
•Initiate, support, and document deviations, OOS, and CAPAs, including investigation, root cause analysis, and effectiveness checks.
•Support document control and SOP lifecycle activities and participate in internal/external audits to maintain continuous inspection readiness.

Pay and Benefits

Salary: USD 70,000 - 85,000 annually

Perks:Health InsuranceDentalVisionParental LeavePaid Leave401kEquity

Key Requirements

•2+ years of experience in Quality Assurance and/or Quality Control within an FDA-regulated environment, with sterile injectable cGMP or 503B outsourcing facility experience strongly preferred.
•Working knowledge of FDA cGMP (21 CFR Parts 210, 211, and 11) and Section 503B of the FD&C Act.
•Working knowledge of USP-NF standards, including <795>, <797>, and <800>, and applicable monographs.
•Aseptic processing experience and familiarity with ISO 14644, contamination control, and sterility-assurance principles.
•Hands-on experience with batch record review, product disposition, and core quality system elements (deviations/CAPA, change control, document control, investigations) in paper and/or electronic QMS (e.g., Trackwise).

Experience:2+ yearsFDA-regulated

Skills:Technical writingCommunicationDocumentationIndependent workDetail-oriented

Tech Stack:TrackwiseQMSEQMS21 CFR Parts 21021 CFR Parts 21121 CFR Part 11503BUSP-NFISO 14644WordExcelVisioPowerPointOutlook

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