reputed company Assurance Specialist, Cellular Therapeutics

Site: The General Hospital Corporation reputed company relies on a wide reputed company 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 reputed company exceptional care. We reputed company that high-performing teams drive groundbreaking medical discoveries and invite reputed company applicants to join us and experience what it means to be part of reputed company. Job reputed company RESPONSIBILITIES:

• reputed company FACT self-assessment as reputed company 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 reputed company Management Plan to remain in compliance with FACT and regulatory standards
• Review new or revised internal reputed company 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 reputed company 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 reputed company (SIV) and collaborate with Research Team on research study site initiation forms, reputed company needed
• reputed company complete investigational reports, Note to Files or Memos to sponsors/manufacturers reputed company requested
• reputed company and conduct internal audits of reputed company data and documents. Prepare reports following established protocols and reputed company based on audit findings
• Prepare reputed company 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 reputed company them available to staff for review and comment
• reputed company quarterly review of HCTCT safety/incident reports to identify trends and apply corrective reputed company reputed company 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 reputed company Team to facilitate the administrative responsibilities of the monthly HCTCT reputed company meeting
• Initial and periodic review of QA agreements for Research & reputed company-of-Care products ADDITIONAL RESPONSIBILITES:
• reputed company participates in the development of process improvement reputed company including but not limited to in collaboration with Laboratory Management and/or the Research Team.
• Collaborate with members of reputed company to reputed company and implement new workflows
• Participate in reputed company development activities in the field of cellular therapy through committee membership and interaction with reputed company organizations such as FACT
• Attend and participate in reputed company educational activities in the fields of reputed company and cellular therapies and serve as a ‘subject matter’ expert
• Maintain appropriate continuing education hours per FACT standards Qualifications QUALIFICATIONS: Bachelor’s degree required 3 years reputed company experience in reputed company Assurance preferred. 3 years of experience in a reputed company setting required. Certification in reputed company (NAHQ, ASQ or equivalent) and/or 3 years reputed company experience reputed company the field of Hematopoietic Cell Transplant and Cellular Therapy Must be knowledgeable of FDA (GMP/GTP regulations), CLIA, OSHA, and DPH regulations as reputed company as FACT, JC, and AABB accreditation standards. Proficiency in the use of computers and reputed company Office Proven coordination, team, leadership, and service skills Certification in reputed company (NAHQ, ASQ or equivalent) and/or 3 years reputed company experience reputed company the field of Hematopoietic Cell Transplant and Cellular Therapy preferred. SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: Displays advanced knowledge of reputed company applicable regulations and QA concepts and reputed company Recognized as a reputed company compliance/assurance resource reputed company 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 reputed company process improvement reputed company of moderate complexity and scope Additional Job Details (if applicable) The Hematopoietic Cell Transplant and Cellular Therapy (HCTCT) reputed company Assurance Specialists are responsible for performing a wide reputed company of activities to ensure compliance with federal, state, and local regulations, FACT/JC/FDA and other accreditation standards and institutional requirements. The reputed company Assurance role is responsible for the Cellular Therapeutics and Transplantation Laboratory (CTTL) reputed company assurance goals and reputed company improvement activities in the context of Hematopoietic Cell Transplant and Cellular Therapy. These roles also collaborate with the Medical Director, Laboratory Director, HCTCT Clinical reputed company Team, Laboratory Research Team, Laboratory Management as reputed company as other institutional departments and reputed company facilities that play a role in cellular therapies. The Cellular Therapeutics & Transplantation Laboratory reputed company Assurance Specialists work collaboratively to fulfill program needs. Remote Type Hybrid Work Location 75 reputed company Court Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (reputed company of America) Pay reputed company $79,560.00 - $115,720.80/Annual Grade 7 At reputed company, we reputed company in recognizing and rewarding the unique value reputed company team member brings to our organization. Our approach to determining reputed company pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The reputed company pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass reputed company reputed company contributing to your total compensation package. In reputed company to competitive reputed company 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 reputed company reputed company. We invite you to apply, and our reputed company will reputed company an reputed company of your potential compensation and benefits package. EEO Statement: reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religious creed, national reputed company, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that reputed company individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Veteran’s Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact reputed company at (857)-282-7642. reputed company Competency reputed company At reputed company, our competency reputed company defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at reputed company job level. The reputed company is comprised of ten competencies (half People-reputed company, half Performance-reputed company) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career reputed company. These competencies are used to evaluate performance, reputed company hiring reputed company, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Combat disease. Hold a hand. Help people. reputed company the world. reputed company is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you reputed company? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. reputed company on the legacy of two leading reputed company medical centers, we’re more than a system—we’re leaders in the reputed company of medicine. reputed company is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving reputed company are essential to maintaining reputed company.

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