Revance · 3 weeks ago
Quality Assurance Specialist III
Newark, CA
Full-time
Onsite
Mid, Senior Level
$900K/yr - $1,050K/yr
4+ years expRevance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. The Quality Assurance Specialist III is responsible for ensuring compliance with quality assurance activities in biologic drug substances and products, supporting various cross-functional teams, and maintaining quality systems.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development and commercial manufacturing
Perform incoming quality attribute inspections; review and disposition of incoming raw materials (e.g. chemicals, packaging and labeling materials, components etc.)
Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports
Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
Review of Quality Control, Analytical Development, and Validation protocols, reports
Perform retain sampling and support the reserve sample program
Perform area approval, line clearance and product inspection
Perform product complaints investigations
Actively update department databases to ensure up-to-date reporting of metrics
Support continuous improvement of quality operations and department databases; author new, revise existing and may review department procedures and/or forms
Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third-party audits
Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
Assist in data verification of DS and DP sections of regulatory submissions as needed
Assist in the internal compliance audits as needed
Qualification
Required
Bachelor's degree & 4-6 years of directly related experience
Ability to work with all levels cross-functionally
Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
Excellent interpersonal and verbal and written communication skills
Good working knowledge of quality systems cGMP standards applicable to commercial biologics DS and DP
Works independently with minimum supervision to accomplish goals
Relies on extensive experience and judgment to resolve simple to moderately complex issues
Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments
Specific vision abilities required by this job include passing a vision test in order to perform statistical inspections of drug products
While performing the duties of this job, the employee is regularly required to stand or sit; converse and listen to individuals; use arms and legs to transfer materials from one location to another; and use hands and fingers to operate a computer and telephone keyboard
This job will require the employee to be able to multi-task different activities and be able to perform duties with attention to detail
Preferred
Minimum 4-6 years' experience in the pharmaceutical or biotechnology industry with at least 4 years working in direct manufacturing, Quality Control, or Quality Assurance; experience in aseptic manufacturing processes is highly desirable
6 years of experience in the pharmaceutical or biotechnology industry with at least 4 years working quality operations involving aseptic fill, finish, and packaging operations is preferred
Prior experience with regulatory inspections is desired
Benefits
Flexible PTO, holidays, and parental leave.
Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
Company
Revance
We believe that science-powered innovation creates possibilities.
1001-5000 employees
H1B Sponsorship
Revance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (16)
2023 (8)
2022 (10)
2021 (16)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.68BKey Investors
Athyrium Capital Management LPEssex Woodlands Healthcare PartnersMedicis Pharmaceutical
2024-08-12Acquired
2024-03-04Post Ipo Equity· $100M
2022-09-12Post Ipo Equity· $200M
Leadership Team
Nadeem Moiz
Chief Executive Officer
Jeffery Bedard
Founder/Executive Chairman Board of Directors
Recent News
MarketScreener
2025-10-27
Company data provided by crunchbase