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Company Description

It takes a lot of very smart, hard-working and talented people to provide the level of care that we give to our patients. Tufts Medical Center is an internationally respected academic medical center and we pride ourselves not only on the sophistication of the care we deliver, but the compassionate way in which we provide it. And that starts with our employees.

Job Description

This position is responsible for developing and overseeing the Quality Assurance policies, regulatory compliance protocols and managing all aspects of the Quality System Essentials (QSE) for all Tufts Medicine (TM) locations within Blood Bank and Transfusion Medicine Services (BBTS), which includes the Transfusion Services, Stem Cell Processing Laboratory and Apheresis. Ensures compliance with relevant standard operating procedures pertaining to the BBTS. Under general direction of the System Quality and Regulatory Director, ensures the compliance with applicable federal and state laws and regulations and accrediting agency standards.

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

• Works directly with the relevant Medical Directors to formulate, establish and implement short- and long-range plans for compliance with regulatory and accrediting agency guidelines, internal and external Quality Assurance programs and policies.
• Based on current standards, performance metrics and best practices, makes recommendations to the Medical Directors as appropriate, on policy and procedure changes in the Blood Bank and Transfusion Service.

Quality Assurance

• Ensures that the BBTS establishes, implements, and maintains a quality system that meets all regulatory standards. Reports on a regular basis to leadership as requested on the performance of the quality system.
• Designs, reviews and approves the validation or verification studies of new processes, equipment, reagents, labels, containers and computer systems to facilitate review by the Medical Directors.
• In conjunction with the System Quality Director, BBTS leaders and Medical Directors develops and establishes appropriate performance measures to guide improvements providing periodic reports as requested.
• Leads or assists with required activities necessary to successfully undergo surveys and inspection including but not limited to preparation of data, mock inspections, written responses and internal reports.
• Responsible for the collection, maintenance and dissemination of federal and state laws, regulations, accrediting agency standards, product licenses and resource materials, and the maintenance of regulatory files. Interprets policies as needed to the Medical Directors and staff. Regulatory and accrediting agencies include but are not limited to CLIA, CAP, JCAHO, FACT, AABB, OSHA, DPH and the FDA.
• Ensure compliance with safety-related reporting processes and associated investigation follow up.
• Serves as liaison between TM BBTS and regulatory and accrediting agencies and responsible for escalating appropriate situations to medical and executive directors.
• Serves as a BBTS subject matter expert and advisor representative at meetings, on committees and councils to support relevant site needs, program development and quality improvement activities within TM

Safety

• Maintains compliance with health and safety regulations.

Miscellaneous

• Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment
• Performs other similar and related duties as required or directed.

Qualifications

JOB KNOWLEDGE AND SKILLS:

• Thorough knowledge of quality assurance, compliance issues and regulatory affairs as applied to blood banks, transfusion medicine, and cell therapy laboratories.

EDUCATION:

• Level of knowledge generally obtained through completion of a bachelor’s of science degree in medical technology or equivalent. Master’s degree strongly preferred.
• Requires the American Society of Clinical Pathology Medical Technology Certification (ASCP) or equivalent.
• Specialist in Blood Bank (SBB) preferred but not required.

EXPERIENCE:

• Minimum of seven to ten years’ progressive experience in Blood Bank and Transfusion Services with Quality Assurance/Improvement experience.
• Track record of successful FDA, FACT and AABB inspections.
• Active user of SoftBank BB software
• Familiarity with MediaLab Quality Management System

An equivalent combination of education and experience which provides proficiency in the areas of responsibility listed above may be substituted for the above education and experience requirements.

WORKING CONDITIONS:

• Normal laboratory working conditions may be subject to blood and human tissue samples.

Additional Information

All your information will be kept confidential according to EEO guidelines.

AMERICANS WITH DISABILITIES STATEMENT:

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

COVID-19 POLICY:

Please note that effective October 1, 2021, as a condition of employment at Tufts Medical Center, all employees and new hires must have received their complete dose of the COVID-19 vaccine, unless they have been granted an exemption.