Quality Assurance Coordinator

QA Coordinator – Investigations & CAPA The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, CAPAs, and compliance with FDA 21 CFR 210/211/11 and ICH Q10 . This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, effectiveness, and maintains inspection-ready documentation to uphold product quality and data integrity. Reporting to QA Supervisor Location Plant Hours Monday – Friday: 8:00am – 4:30pm 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, recommend process or procedural improvements, and report 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. Qualifications Education & Experience 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. Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills 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. Key Competencies 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 delivers on commitments with minimal supervision. Working Conditions Primarily office-based with routine interaction in manufacturing and laboratory environments. May require off-shift or weekend support during audits, investigations, or operational escalations. Occasional travel may be required for training or supplier quality support. 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. This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job." Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr