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QA & REGULATORY COMPLIANCE ASSOCIATE, (GCP Audits) DCRI

Req ID:  8647
Date:  Oct 12, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

POSITION SUMMARY:

Independently plan, conduct and manage all audit related activities for internal audits, vendor audits and clinical site audits; Independently plan, facilitate and manage all audit related activities related to sponsor audit and regulatory inspection facilitation.

GCP or Computer Systems Validation experience highly preferred

 

WORK PREFORMED:

Internal Audits:

Plan and conduct internal audits to ensure that studies are conducted in accordance with sponsor protocols, standard procedures, GCP, appropriate regulations and guidance.Evaluate maintenance of documentation against the applicable regulatory standards and contractual obligations. Prepare and distribute audit reports. Prepare and distribute Audit Observation Reports to the auditee s, review and assess observation responses and when applicable, Corrective and Preventive Action (CAPA) plans provided by the auditees. Continue follow up with the auditees until Audit Observation Reports are completed and closed.

 

Vendor Audits:

Plan and conduct external audits of subcontractors for the purpose of vendor evaluation, including due diligence review, vendor audits, and periodic re-evaluations. Prepare and distribute audit reports. Prepare and distribute Audit Observation Reports to the auditees, review and assess observation responses and when applicable, Correctiveand Preventive Action (CAPA) plans provided by the auditees. Continue follow up with the auditees until Audit Observation Reports are completed and closed.

 

Site Audits:

Plan and conduct clinical site audits to ensure that studies are conducted in accordance with sponsor protocols, standard procedures, GCP, appropriate regulations and guidance. Evaluate maintenance of documentation against the applicable regulatory standards and contractual obligations. Prepare and distribute audit reports. Prepare and distribute Audit Observation Reports to the auditees, review and assess observation responses and when applicable, Corrective and Preventive Action (CAPA) plans provided by the auditees. Continue follow up with the auditees until Audit Observation Reports are completed and closed.

 

Sponsor Audits:

Plan and facilitate spons or audits. Serve asprimary interface with sponsor auditor(s). Create and provide the audit agenda to the auditor(s) and internal participants.

Conduct pre-audit meeting to aid in audit preparation for the auditees. Provide sponsor audit observations to the internal auditees, collect observation responses and action commitments (CAPA) fromall involved in audit, send the responses to the sponsor on a timely manner and by the due date. Continue follow up with the auditees until observation responses and CAPA commitments are completed and closed.

 

Regulatory Inspections:

Plan and facilitate regulatory inspections. Serve as primary interface with inspector(s). Create and provide the inspection agenda to internal participants. Conduct pre-audit meeting to aid in inspection preparation for the auditees. Provide inspection findings to the internal auditees, collect inspection responses and action commitments (CAPA) from all involved in the inspection, send the responses to the inspector on a timely manner and by the due date. Continue follow up with the auditees until responses and CAPA commitments are completed and closed. Lead process improvements through leading the creation and revision of DCRI QSDs as a QA Contact; Apply Lean Six Sigma principles to produce effective, efficient and clear cross-functional processes; Incorporate Quality By Design principles to meet regulatory requirements

 

GCP and Computer System Valiation (CSV) experience highly preferred.

 

Minimum Qualifications

Education

Work generally requires a bachelor's degree in Pharmacy, Chemistry or a life science. "

Experience

Work requires six years of experience in quality assurance or quality control related to clinical trials materials packaging and distribution and/or pharmaceutical manufacturing. 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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh