Quality Investigation Specialist

POSITION SUMMARY:  
This position is responsible for conducting investigations of assigned non-medical quality incidents and coordinating corrective action and preventive action (CAPA), as appropriate, in support of the organization’s strategic objectives to assure continuing compliance with FDA cellular therapy regulations, and promote highest standards of safety for donors, patients and products. Collaborates with key stakeholders, including internal personnel within Operations, Medical Services, other NMDP departments, and network center staff to resolve quality incidents. Participates in projects pertaining to incident management processes and systems, regulatory compliance, and process improvement as assigned.

ACCOUNTABILITIES: 
Quality Incident and Complaint Management:
•    Participates in investigation of non-medical quality incidents requiring complex problem solving and operational expertise.
•    Utilizes the online quality management software system to facilitate and record incident management activity.
•    Systematically conducts investigations of assigned quality incidents, to include the following steps:
o    preliminary investigation
o    remedial action
o    risk assessment
o    submission of completed quality incident investigations for review and approval
•    Coordinates and leads assigned Corrective Action/Preventive Action (CAPA) to include:
o    detailed investigation of assigned CAPA, to include determination of root cause(s) of the problem
o    planning and recommendation of a potential corrective action or preventive action plan and proposed effectiveness checks for measuring the success of the CAPA
o    implementation, with monitoring and documentation of completion of the corrective/preventive actions and associated tasks
o    effectiveness checks, with monitoring and documentation of completion and acceptability of the results
o    submission of a CAPA report for final review and closure

Process and Project Work:
•    Participates in projects pertaining to incident management processes and systems, regulatory compliance, and process improvement as assigned.

Additional Accountabilities:   
•    Maintains current knowledge of relevant operational processes by attending appropriate internal meetings and completion of appropriate education and training.
•    Other duties as assigned, in support of NMDP’s mission and goals.

REQUIRED QUALIFICATIONS: 
Knowledge of:
•    Principles of quality assurance, risk management, and confidentiality; strong knowledge of cellular therapy transplantation and associated operations.

Ability to:
•    Demonstrate excellent oral and written communication; advanced interpersonal skills in  collaborating with others to gather information; complex problem solving, analysis, and decision making; customer service; proficiency in using relevant NMDP computer software applications; proficiency with Windows, Word, Excel, PowerPoint, internet and databases preferred.
•    May require some flexibility in work hours.

Education and/or Experience:
•    Bachelor’s degree; Healthcare or Science field strongly preferred. On evaluation, equivalent related experience and/or education may be substituted for the degree requirements.
•    Five years of experience in a healthcare or science environment. Two years of experience related to investigation and resolution of complaints and non-conformances.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
•    Certification in process improvement or other quality management function.