The Cell Manufacturing Quality Specialist I participates in monitoring operations and quality improvement initiatives by gathering quality data and reviewing metrics to assist in ensuring that systems are safe, effective, appropriate, compliant, current and adhered to by CMCF staff.?? The Cell Manufacturing Quality Specialist I builds understanding of quality management practices to the monitoring and improvement of CMCF operations.
This position is a fully onsite position in the Longwood Medical Area.
The Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) assists DF/HCC members in developing new cell-based therapies for patients with cancer who are enrolled in novel therapeutic clinical research protocols. It also supports clinical research studies designed to evaluate the safety and efficacy of these novel treatments.?? Please visit????https://cmcf.dana-farber.org
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
PRIMARY DUTIES AND RESPONSIBILITIES:
Perform established batch record review, assess completeness and accuracy in conjunction with expected outcome with assistance as needed.
Perform selected data analysis and reporting with assistance.
Assist with audits.
Assist with process improvement projects.
Participate in in deviation reports, planned deviation reports and non-conforming reports.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Ability to effectively and efficiently manage time and responsibilities to ensure deadlines are met.
Ability to maintain patient privacy, patient safety and protect intellectual property.
Ability to effectively work as part of a team, including collaboration, negotiation, transparency, identifying issues and solutions.
Ability to carry out complex calculations for dosing of cell therapy product based on clinical trial.
Strong skills in Microsoft Office applications.
Ability to work in a fast-paced environment, effective in a diverse work group, willing to work in a rapidly changing field.
Maintain basic knowledge of applicable standards and regulations to ensure department/institution ongoing compliance with accreditation standards (FACT, JC) and inspection regulations (FDS, DPH, CMS, DOT).
Pursues continuing education.
Becomes familiar with basic applicable standards and regulations.
MINIMUM JOB QUALIFICATIONS:
Minimum Education: ?????? BS/BA in Science, Medical Technology or related field required.
Minimum Experience: ?? 1 year of clinical, pharmaceutical, cell manufacturing or laboratory experience.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.?? As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.?? Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.