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SR. QA/RC AUDITOR
Job Title: SR. QA/RC AUDITOR
Job Code: 1235
FLSA: E
Job Level: 15
Revised Date: 12/01/2023
Job Family: JF 28
Occupational Summary
Under general direction, performs a variety of activities involved in assuring compliance with regulatory requirements by conducting audits, training programs, and reviewing and analyzing data and documentation. Provide internal quality and regulatory compliance consulting to other departments.
Work Performed
Internal Audits
Develop a quality assurance and regulatory compliance strategy.
Independently plan and manages all audit related activities for internal audits and sponsor audit facilitation, and third party vendors including CROs, technology vendors, and laboratories.
Conduct internal project audit to ensure that studies are conducted in accordance with sponsor protocols, standard procedures, GCP, appropriate regulations and guidance.
Plan, supervise, and perform audits.
Conduct internal process audit to evaluate the internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external procedures, and quality and regulatory standards.
Prepare and distribute audit reports.
Provide audit observations to the auditees, review and assess.
Corrective and Preventive Action (CAPA) provided by the auditees.
Continue follow up with the auditees until all CAPA items are completed and closed.
Sponsor Audits Plan and prepare for sponsor audits.
Provide the audit agenda to the auditor/s and internal participants.
Facilitate sponsor audits.
Provide sponsor audit observations to the internal auditees, collect responses and CAPA from all involved in audit, send the responses to the sponsor on a timely manner and by the due date.
Vendor Audits
Conduct external audits of subcontractors for the purpose of vendor qualification, including due diligence review, vendor site audits, and periodic re-evaluations.
Prepare and distribute audit reports.
Provide audit observations to the auditee, review and assess.
Corrective and Preventive Action (CAPA) provided by the auditee.
Continue follow up with the auditee until all CAPA items are completed and closed.
Site Audits Support and/or conduct investigative site audit activities.
Provide audit observations to the auditee, review and assess.
Corrective and Preventive Action (CAPA) provided by the auditee.
Continue follow up with the auditee until all CAPA items are completed and closed.
Consulting
Provide consulting on SOP compliance, planned and unplanned deviation to other departments.
Provide consulting on regulatory compliance to other departments.
Regulatory Inspections
Participate in inspection readiness plans and activities.
Facilitate regulatory inspection Quality Systems Draft, revise, and update.
Quality Assurance
SOPs and other QSD documents.
Review and approval of SOPs.
Provide consultation with the development of their SOPs.
Develop quality and risk assessment tools and checklists.
Process Improvement Facilitate problem resolution and issue escalation.
Perform root cause analysis to identify source of problems or non conformances.
Analyze and propose best practices for implementing and conducting audits and investigations.
Training
Stay current with regulatory, quality, and industry trends related to GCP Serve as a mentor to other QA/RC auditors and provide performance feedback to them.
Oversee department training and development including identification of training needs.
Educate internal and external partners on Quality Management System
Required Qualifications at this Level
Education/Training
Work generally requires a BA/BS in a scientific discipline.
Experience
A minimum of 7 years of experience in pharmaceutical, healthcare, medical devices, biotech, or clinical trial contract research industry, including minimum 2 years of experience in Quality Assurance and Regulatory Compliance/ Affairs.
A Master's degree in a related field may be substituted for 2 years of required experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
Strong analytical, problem solving skills
Excellent written and verbal communication and interpersonal skills
Detail oriented, good organizational traits
Results oriented, multi tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines
Good computer skills; inclination to adopt technology to maximize efficiency
Self motivated, with strong leadership abilities
Complete understanding of drug development and clinical trial process
Must have knowledge of 21 CFR 11, 45, 50, 56, 312, 812 45 CFR 46, 74 42 CFR 50 ICH E6 , ICH E9
FDA Guidance on General Principles of Software Validation
FDA Guidance on Computerized Systems Used in Clinical Investigations
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
