Strategic Service Associate - Adult and Pediatric Bone Marrow Transplant

Overview

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.

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 Health hospitals 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

• 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

• 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

• Review and approve Change Control Records (CCRs) in the document control system Master Control
• 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

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

Education

Bachelors degree in a business or health-related field is required. Masters  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

• 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 Master Control 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.

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