Quality Specialist, Hims & Hers
$70-85k
Plus equity
Office located in Los Alamitos, CA
Multi-specialty telehealth platform
Be an early applicant
Multi-specialty telehealth platform
1001+ employees
Be an early applicant
$70-85k
Plus equity
Office located in Los Alamitos, CA
1001+ employees
Company mission
To help the world feel great through the power of better health.
Role
Who you are
- 2+ years of experience in Quality Assurance and/or Quality Control within an FDA-regulated environment; 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, in-process and finished-product inspection, and product disposition against defined specifications
- Experience with core quality system elements — deviations/CAPA, change control, document control, and investigations — within paper and/or electronic QMS (e.g., TrackWise)
- Experience supporting internal and regulatory (e.g., FDA) audits and inspections
- Strong foundation in root cause analysis, risk assessment, and statistical/trend analysis
- Excellent technical writing, documentation, and verbal/written communication skills
- Strong computer skills (Word, Excel, Visio, PowerPoint, Outlook); familiarity with eQMS (e.g. Trackwise) a plus
- Ability to prioritize and work independently in a fast-paced environment; a highly motivated, detail-oriented self-starter
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match
What the job involves
- The Quality Specialist is an individual contributor within the site Quality Unit, supporting Quality activities in a sterile injectable cGMP / 503B environment
- The role executes day-to-day quality oversight “on the floor” and within the Quality Management System (QMS) — including in-process and finished-product oversight, batch record review, environmental monitoring support, deviations and CAPA, change control, document control, and investigations — to ensure products meet identity, strength, quality, purity, and sterility-assurance requirements in alignment with 21 CFR Parts 210, 211, and 11, Section 503B of the FD&C Act, and USP standards
- Working under the direction of QA management, the Quality Specialist supports release and disposition activities, identifies and escalates significant quality events, and helps sustain a state of continuous inspection readiness and a culture of compliance and continuous improvement
- Provide in-process and finished-product quality oversight on the manufacturing floor, including monitoring of manufacturing and aseptic processing operations for compliance with approved procedures, cGMP, and USP standards
- Perform batch record review and support batch disposition, verifying that documentation, testing, and investigations are satisfactorily completed prior to release in accordance with approved procedures
- Review and provide input on procedures, specifications, master/executed batch records, and controlled forms to ensure accuracy, completeness, and regulatory compliance
- Support the environmental monitoring (EM) program, including review of data and prompt escalation of excursions and adverse trends
- Support packaging and labeling controls, including label issuance, reconciliation, and verification to prevent mix-ups and labeling errors
- Assist with incoming material inspection and material control — sampling, Certificate of Analysis (COA) review and acceptance, and disposition of components and raw materials
- Support vendor/supplier quality oversight and the management of contract-laboratory testing, including sample submission, tracking, and review of results
- Support document control and the SOP lifecycle — authoring, revision, routing, and periodic review of GMP documentation — and maintain a current, compliant, audit-ready repository
- Initiate, support, and document deviations, OOS, and CAPAs, including investigation, root cause analysis, and verification of effectiveness
- Support quality system programs including, change control, document control, training, complaints, quality event management, etc. and the implementation of Trackwise eQMS
- May serve as a process owner for an element of the quality system, based on experience and background
- Support risk management and assessment activities for assigned areas
- Participate in internal and external (third-party and regulatory) audits and help maintain continuous inspection readiness
- Support preparation of the Annual Product Quality Review (APQR) through data compilation and trending
Our take
Hims & Hers is a direct-to-consumer brand made for men and women, offering products for skin care, birth control, erectile dysfunction, hair loss and more. The company aims to create an open and honest culture of care that is accessible for everyone, no matter who you are or where you live.
Hims & Hers approach healthcare differently through a telemedicine approach combined with a comprehensive wholesale and branding strategy. This allows customers to get diagnosed and treated at a lower cost and with greater convenience whilst the company simultaneously increases customer brand's presence across the US.
The company is increasingly focused on becoming a modern healthcare brand, and has a huge addressable market to go after. The recent launch of an app has helped it grow significantly too. Further, its focusing investment into platform infrastructure and the development of partnerships with physical stores including retail giant Walmart, as well as continuing to launch new products such as its range of volumizing shampoos. Altogether, these moves put the brand in a good position for long-term growth as it looks to scale and evolve even further.
Steph
Company Specialist at Welcome to the Jungle
Insights
38% employee growth in 12 months
Company
Funding (last 2 of 4 rounds)
Jan 2019
$100m
LATE VC
Jul 2018
$50m
SERIES B
Total funding: $197m
Company benefits
- Full healthcare: High-coverage medical, dental & vision coverage for individuals and families
- Generous PTO: Take the time you need, when you need it - including generous parental leave
- Retirement planning: Take advantage of our 401(k) plan including contribution matching
- Work from anywhere: We are a remote-first company, so you can work from anywhere you like in the uS
- Robust compensation: We offer competitive salary bands and stock options
- Employee discount: Employees can take advantage of product discounts
- Utility stipend: A extra $75 each month to cover extra cell phone, internet, or data usage
- Spending accounts: Options for additional HSA and FSA plans to help toward healthcare costs
Company HQ
Marina District, San Francisco, CA
Leadership
Andrew Dudum
(Founder & CEO)Previously co-founder of Atomic, Homebound, Terminal and Bungalow and Investor & Advisor at Stable Auto, TalklQ, and Mira Technologies.
Jack Abraham
(Co-Founder & Investor)Founder and Managing Partner of Atomic. Co-Founder and Investor at Replicant, Raydiant, Bungalow, Homebound, Terminal and Zenreach.
Salary benchmarks
We don't have enough data yet to provide salary benchmarks for this role.
Submit your salary to help other candidates with crowdsourced salary estimates.
Share this job
View 21 more jobs at Hims & Hers