Revance · 9 hours ago
Quality Assurance Coordinator
Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings. The QA Coordinator – Investigations & CAPA will support site Quality Systems by managing deviations and CAPAs, ensuring compliance with FDA regulations, and maintaining inspection-ready documentation to uphold product quality and data integrity.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10
Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence
Develops and manages Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines
Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership
Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready
Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or related technical field required
Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment
Demonstrated expertise in managing deviations and CAPAs
In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7–Q10, and relevant USP chapters
Proficiency in root cause analysis tools and Six Sigma methodologies
Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance
Familiarity with data integrity requirements and ALCOA+ compliance
Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification
CAPA Execution: Ensures timely, effective, and risk-based corrective actions
Compliance Stewardship: Upholds data integrity and documentation standards across all QA systems
Collaboration: Works effectively across departments to align investigation outcomes with operational needs
Accountability: Tracks and deliveries on commitments with minimal supervision
Preferred
Experience with FDA inspections and supporting regulatory audits is highly preferred
Benefits
Competitive Compensation including base salary and annual performance bonus
Paid time off, holidays, and floating holidays that can be used for whatever you choose
Generous healthcare benefits
Employer HSA match
401k match
Wellness discounts and much more
Company
Revance
We believe that science-powered innovation creates possibilities.
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 (8)
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
Recent News
MarketScreener
2025-10-27
Company data provided by crunchbase