Quality Investigation Specialist

NMDP•Minneapolis, MN

1d•$70,000 - $85,000

About The Position

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.

Requirements

Knowledge of principles of quality assurance, risk management, and confidentiality.
Strong knowledge of cellular therapy transplantation and associated operations.
Excellent oral and written communication skills.
Advanced interpersonal skills in collaborating with others to gather information.
Complex problem solving, analysis, and decision making skills.
Customer service skills.
Proficiency in using relevant NMDP computer software applications.
Proficiency with Windows, Word, Excel, PowerPoint, internet and databases.
Bachelor’s degree in Healthcare or Science field strongly preferred, or equivalent related experience and/or education.
Five years of experience in a healthcare or science environment.
Two years of experience related to investigation and resolution of complaints and non-conformances.

Nice To Haves

Certification in process improvement or other quality management function.

Responsibilities

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 preliminary investigation, remedial action, risk assessment, and submission of completed quality incident investigations for review and approval.
Coordinates and leads assigned Corrective Action/Preventive Action (CAPA) to include detailed investigation of assigned CAPA, determination of root cause(s), planning and recommendation of a potential corrective action or preventive action plan and proposed effectiveness checks, implementation with monitoring and documentation of completion, and effectiveness checks with monitoring and documentation of completion and acceptability of the results.
Participates in projects pertaining to incident management processes and systems, regulatory compliance, and process improvement as assigned.
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.