What are the responsibilities and job description for the Quality Assurance Specialist, Cellular Therapeutics position at Massachusetts General Hospital?
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 staff's 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
The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
QUALIFICATIONS:
- Bachelor's 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.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
- 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
The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.