The Quality Specialist plans, coordinates, monitors, and performs TMS Quality System functions pertaining to Quality Control, Quality Assurance, Quality Improvement, Document Control, and Regulatory Compliance.
Communicates quality activities to management. Coordinates the design, collection, and monitoring of quality measures/metrics for reporting to sectional/departmental management for quality assurance providing objective, unbiased observations to ensure compliance with current manufacturing practice as defined by FDA.
Acts as liaison to departmental quality committees and managers. Works with the Pathology quality management team to ensure the TMS is in compliance with all departmental and institutional standards and regulations.
Manages the transfusion medicine service quality plan, which consists of policy and process documents that direct quality functions of all TMS operations.
Coordinates sectional preparation for all regulatory reviews.
Facilitates internal assessments and audits, to assess the effectiveness of process improvement initiatives, and to report to the transfusion committee regarding the status of current good manufacturing practices.
Integrates new quality management directions into TMS operations.
Participates in writing the TMS documents and implements new versions of SOPs in each area of TMS. Monitors and assesses compliance training and maintenance of current good manufacturing practices program.
Participates in occurrence management. Reviews and summarizes/refers periodic quality reports.
Coordinates with the transfusion safety officer on issues related to quality of services provided by TMS.
Participates in TMS laboratory proficiency programs. Ensures appropriate scope, periodicity, and compliance with departmental and extra-mural regulatory requirements.
Acts as an informational sciences resource to section. Designs, collects, formats, and interprets TMS statistics as required by regulatory agencies, using various information systems as sources of data to compile TMS monthly reports, TMS performance measures, TMS quality assurance reports, and transfusion committee reports, among others.
Performs other duties as required or assigned.
Bachelor’s degree with 4 years of experience in blood banking required.
Familiarity with cellular and tissue transplantation and blood donor program services preferred.
Circumspect problem-solving skills and good mathematical and computer skills including competence in Microsoft Office required.
Excellent interpersonal and communications skills, consensus building skills, and a team approach required.
Maintains a current working knowledge of all relevant laws, regulations, and industry standards.
Required Licensure/Certification Skills:
MT (ASCP) or equivalent certification required.
Specialty laboratory certification and advanced training/certification in Quality Systems Management preferred.
The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. With destinations like Boston, New York, the seacoast and ski country within driving distance, the opportunities - both career and personal - truly make New Hampshire the ideal place to work and play.
Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, veteran status, gender identity or expression, or any other characteristic protected by law.