SR. QA/RC AUDITOR, DCRI - QA & Regulatory Compliance

Location
Durham, NC
Posted
Mar 03, 2018
Institution Type
Four-Year Institution

diversity employer



SR. QA/RC AUDITOR, DCRI - QA & Regulatory Compliance
Quality Assurance & Regulatory Complianc

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

OCCUPATIONAL SUMMARY

Perform 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

Auditing
-Develop a quality assurance and regulatory compliance strategy for the DCRI. 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.

-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.

-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.

-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.

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 SOP's and other QSD documents.

-Review and approval of DCRI SOP's. Provide consultation to all DCRI departments with the development of their SOP's.

-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



Requisition Number
401384826

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1235 SR. QA/RC AUDITOR

Job Family Level
15

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications


Education

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

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.

Auto req ID

97892BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

PI101437651

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