Revance
Job Summary
Job Summary:
The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, 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 Reporting to:
QA Supervisor
Location Location:
Plant
Hours Hours:
Monday - Friday: 8:00am - 4:00pm
Responsibilities/Essential Duties
Investigations and CAPA Management
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.
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 deliveries 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
Company Summary Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you
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.
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The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, 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 Reporting to:
QA Supervisor
Location Location:
Plant
Hours Hours:
Monday - Friday: 8:00am - 4:00pm
Responsibilities/Essential Duties
Investigations and CAPA Management
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.
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 deliveries 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
Company Summary Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you
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