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About Duke University Hospital

Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.

Duke Nursing Highlights:

• Duke University Health System is designated as a Magnet organization
• Nurses from each hospital are consistently recognized each year as North Carolina's Great 100 Nurses.
• Duke University Health System was awarded the American Board of Nursing Specialties Award for Nursing Certification Advocacy for being strong advocates of specialty nursing certification.
• Duke University Health System has 6000 + registered nurses
• Quality of Life: Living in the Triangle!
• Relocation Assistance (based on eligibility)

Work arrangement - onsite - North Pavilion, 8th floor 

Position Summary 

The Strategic Services Associate (SSA) will support the Adult and Pediatric Bone Marrow Transplant clinical quality programs (APBMT CQP) and act as a liaison to the Stem Cell Laboratory (STCL), providing cross-coverage for all three departments as needed to support clinical operations.

KEY RESPONSIBILITIES

Quality & Regulatory Compliance

• Maintain compliance with Foundation for the Accreditation of Cellular Therapy (FACT), Duke, FDA, and commercial partner requirements for BMT cellular therapy programs (Adult and Pediatrics) and the Stem Cell Laboratory (STCL)
• Support FACT inspection preparation, onsite activities, and closure processes (every 3 years)
• Support CAP (College of American Pathology) inspection preparation, onsite activities, and closure processes for the STCL (every 2 years)
• Support during other inspections, as deemed necessary

Daily Operations & Product Release

• Assist in quality supply inspection and product release
• Perform Urgent Medical Need Review/Release of products
• Complete Review of facility logs and records (ie. monthly, quarterly, etc)
• Review and approve Deviations, Investigations, Corrective Actions, Complaints, and Adverse Events for clinical programs

Change Control & Validation

• Review and approve Change Control Records (CCRs) in the document control system MasterControl
• Initiate CCRs as needed for document, software, equipment, or facility changes
• Provide guidance on CCR initiation and completion requirements
• Provide guidance when completing risk assessments
• Review, draft, and approve validation plans and reports

Committee & Reporting

• Assist in APBMT Quality Assurance Committee meetings
• Organize, track, and trend quality metrics
• Report quality metrics to QA Committee

Minimum Qualifications

Education

Bachelors degree in a business or health-related field is required. Master's degree preferred 

Experience

• Minimum of 5 years work experience
• 3 years of experience with significant quality/regulatory compliance or process improvement responsibility in a clinical laboratory or healthcare setting. 
• Experience leading work teams required. 

Knowledge, Skills and Abilities

• Effective written and verbal communication skills.
• Ability to communicate with customers/staff with diverse educational backgrounds.
•  Analysis of data and processes for opportunities for improvement.
• Ability to manage numerous diverse projects simultaneously through effective priority setting, efficient use of time, organization
• Knowledge of accreditation standards and regulations related to health care
• Attention to detail and accuracy.
• Computer literacy

Preferred Qualifications 

• Regulatory Knowledge: FACT standards, FDA regulations (21 CFR Part 1271), cGMP/cGTP requirements, and CAP standards
• Clinical Experience: Stem cell processing, apheresis, BMT, or cellular therapy operations
• Quality Systems: Proficiency with MasterControl or similar quality management systems
• Technical Skills: Microsoft Office Suite (Excel, Word, PowerPoint), FDA reporting systems (BPDR)
• Analytical Skills: Root cause analysis, risk assessment, CAPA development
• Communication: Strong written/verbal skills for regulatory agencies, sponsors, clinical staff, and committees
• Organizational Skills: Ability to manage multiple priorities, inspection timelines, and interdependent processes

Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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.

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