Quality Assurance Specialist, Cellular Therapeutics

Site: The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

The Hematopoietic Cell Transplant and Cellular Therapy (HCTCT) Quality Assurance Specialists are responsible for performing a wide variety of activities to ensure compliance with federal state and local regulations FACT/JC/FDA and other accreditation standards and institutional requirements. The Quality Assurance role is responsible for the Cellular Therapeutics and Transplantation Laboratory (CTTL) quality assurance goals and quality improvement activities in the context of Hematopoietic Cell Transplant and Cellular Therapy. These roles also collaborate with the Medical Director Laboratory Director HCTCT Clinical Quality Team Laboratory Research Team Laboratory Management as well as other institutional departments and outside facilities that play a role in cellular therapies.

The Cellular Therapeutics & Transplantation Laboratory Quality Assurance Specialists work collaboratively to fulfill program needs.

Job Summary

RESPONSIBILITIES:

Perform FACT self-assessment as well as coordinate compile and submit requested documentation in preparation for the FACT accreditation inspection and follow-up on any citations or findings post inspection
Review and assist with completion of Requests for Information (RFI)
Review of non-conforming forms
Work collaboratively with Laboratory leadership to maintain and update the laboratory Quality Management Plan to remain in compliance with FACT and regulatory standards
Review new or revised internal standard operating procedures job aides worksheets and forms to ensure compliance with FDA regulations and FACT requirements. Approve policies and procedures for the processing laboratory and clinical program
Review and approve new or revised Cellular Therapy product manuals protocols and forms (provided by sponsor/manufacturer) and ensure compliance with FDA regulations and FACT requirements.
Review and approve investigational Cellular Therapy related protocol amendments Note-to-File Memos etc.
Review and approve validation plan(s) and completed validations including those for equipment and procedures.
Review CTTL staffs training and competencies
Review and investigate occurrence/safety/incident reports and conducts RCA/CAPAs as needed.
Participate in site initiation visits (SIV) and collaborate with Research Team on research study site initiation forms when needed
Provide complete investigational reports Note to Files or Memos to sponsors/manufacturers when requested
Develop and conduct internal audits of complex data and documents. Prepare reports following established protocols and methods based on audit findings
Prepare quality management reports and annual summaries for the HCTCT Program
Work with Laboratory Management to prepare monthly QM reports with to identify problems trends and CAPA and make them available to staff for review and comment
Perform quarterly review of HCTCT safety/incident reports to identify trends and apply corrective action when a deviation has been identified
Responsible for monthly and quarterly reporting of total bone marrow harvests non-conforming products contaminants accidents errors and complaints.
In compliance with FACT standards work with the HCTCT Clinical Quality Team to facilitate the administrative responsibilities of the monthly HCTCT Quality meeting
Initial and periodic review of QA agreements for Research & Standard-of-Care products

ADDITIONAL RESPONSIBILITES:

Actively participates in the development of process improvement projects including but not limited to in collaboration with Laboratory Management and/or the Research Team.
Collaborate with members of the team to develop and implement new workflows
Participate in standard development activities in the field of cellular therapy through committee membership and interaction with professional organizations such as FACT
Attend and participate in professional educational activities in the fields of quality and cellular therapies and serve as a subject matter expert
Maintain appropriate continuing education hours per FACT standards

• Bachelors degree required
• 3 yearsprofessional experience in Quality Assurance preferred.
• 3 years of experience in a healthcare setting required.

• Certification in Quality (NAHQ ASQ or equivalent) and/or 3 years professional experience within the field of Hematopoietic Cell Transplant and Cellular Therapy
• Must be knowledgeable of FDA (GMP/GTP regulations) CLIA OSHA and DPH regulations as well as FACT JC and AABB accreditation standards.
• Proficiency in the use of computers and Microsoft Office
• Proven coordination team leadership and service skills
• Certification in Quality (NAHQ ASQ or equivalent) and/or 3 years professional experience within the field of Hematopoietic Cell Transplant and Cellular Therapy preferred.

• Displays advanced knowledge of all applicable regulations and QA concepts and practice
• Recognized as a quality compliance/assurance resource within own department
• Demonstrates effective self-sufficient communication skills including peer-directed presentations
• Demonstrates ability to plan and execute appropriate test systems and validations
• Has ability to lead process improvement projects of moderate complexity and scope

Hybrid

75 Blossom Court

40

Regular

Day (United States of America)

Pay Range

$79560.00 - $115720.80/Annual

Grade

7

At Mass General Brigham we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive and any offer extended will take into account your skills relevant experience if applicable education certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation addition to competitive base pay we offer comprehensive benefits career advancement opportunities differentials premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religious creed national origin sex age gender identity disability sexual orientation military service genetic information and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

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