CAPA Investigation professional

4 weeks ago

Saginaw, United States Versiti Inc. Full time

Overview:

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary:

Under the supervision of Manager/Director, or designee, performs quality investigations, determines corrective action/preventative action and monitors effectiveness evaluations. Collaborates interdepartmentally and across affiliates to ensure investigations and corrective actions are appropriate prior to implementation..

Responsibilities:
  • Responsible for assuring compliance with Quality SOPs to assess and to ultimately classify risk for Quality Investigations. Individual is responsible for determining final disposition of blood product (quarantine, release to inventory or discard).
  • Document investigations, corrective actions and effectiveness verifications within the electronic or manual Quality Management System locally and across affiliates as needed. Determines the key elements of the investigation, including defining, measuring, and analyzing the why the error occurred through detailed investigation using RCA methodology.
  • Performs detailed investigations including root cause analysis and coordinates across Versiti affiliates as needed to standardize processes and/or SOPs. Develops and implements changes to SOPs were needed to support corrective actions and trends identified. Collaborates with Operational Leadership across Versiti affiliates along with the technical writers and training department to ensure changes are implemented in a timely manner.
  • Collaborates with Operational Leadership, Quality and Operational Excellence to determine corrective action/preventative action needed (CAPA) using critical thinking and independent decision making.
  • Performs tracking and trending of Quality investigations. Upon identifying a trend, notifies Operational Leadership, Quality and Operational Excellence to determine if further investigation and corrective action are required.
  • Ensures effectiveness evaluation is clear, concise and documented in a timely manner. Develops comprehensive investigational plans and presents them to management and quality. Responsible to make recommendations for adjustments and changes to SOPs from investigation findings.
  • Coordinates with and provides support for staff working on Quality investigations across Versiti affiliates for standardization of investigations and corrective actions. Provides guidance to employees in the interpretation of technical issues across interdisciplinary teams.
  • Informs Quality and Operational Excellence and Operational Leadership of the status and resolution of Quality investigations.
  • Works to complete tasks and documentation following the time frame designated within the established SOP.
  • Collaborates with technical writers to update SOPs where needed as corrective action.
  • Maintains competency and assists in operations as needed to retain skills needed as Subject Matter Expert.
  • Maintain and comply with all assigned eQMS and Corporate trainings.
  • Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
  • Understands and performs in accordance with all applicable regulatory and compliance requirements
  • Complies with all standard operating policies and procedures


Qualifications:

Education

  • Bachelor's Degree in a related field required
  • High School Diploma or equivalent, plus an additional four years experience in blood banking to include demonstrated responsibilities performing process improvement, risk assessment, and compliance management (Five years overall required) in lieu of required degree

Experience

  • 1-3 years One year experience in blood banking to include demonstrated responsibilities performing process improvement, risk assessment, and compliance management (five years if HS Diploma/GED). required

Knowledge, Skills and Abilities

  • Ability to read and interpret documents such as Standard Operating Procedures, safety rules, operating and maintenance instructions, and other department materials required
  • Demonstrated knowledge of Food and Drug Administration (FDA) regulations and American Association of Blood Banks standards (AABB). required
  • Ability to perform tracking, trending and root cause analysis required
  • Knowledge of process improvement techniques required
  • Skills necessary to manage complex, multi-functional investigations required required
  • Excellent oral and written communication skills to include technical writing and presentation skills required
  • Be able and available to work a flexible working schedule as required based on volume and timing of blood collections. required
  • Ability to indirectly lead others, communicating effectively with front line staff and leadership. required

Tools and Technology

  • Personal Computer (desktop, laptop, tablet) required
  • General office equipment (computer, printer, fax, copy machine) required
  • Microsoft Suite (Word, Excel, PowerPoint) required

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