Cell Manufacturing Quality Specialist

Overview

The Cell Manufacturing Quality Specialist II independently monitors operations and quality improvement initiatives by gathering and reviewing quality data and preparing reports to assist in ensuring that systems are safe, effective, appropriate, compliant, current and adhered to by CMCF staff. The Cell Manufacturing Quality Specialist II builds understanding of quality management practices to the monitoring and improvement of CMCF operations.

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 (Use the "Apply for this Job" box below)..org

This is a full time position, Monday through Friday, including an on-call requirement. This position is 100% on-site and the Dana-Farber Longwood location.

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.

• Perform novel and complex batch record review, assess completeness and accuracy in conjunction with expected outcome.
• Applies knowledge and competence of process being reviewed, authority to not release product if inaccuracies are found and endpoints have not been met.
• Perform complex data analysis and reporting.
• Perform audits, compile findings and, suggest recommendations; if applicable, share with staff and management.
• Participate in process improvement projects.
• Perform deviation reviews with assistance as required.
• Oversight and management of internal CMCF audits and select external audits.
• Participate in RCA (root cause analysis)/CAPA (corrective and preventative action plans).
• Participate in review of validation plans and completed validations.
• Participate in document control system by supporting multidisciplinary teams in developing controlled documents.
• Suggest new areas to audit for possible improvements.
• Maintain a good foundation knowledge of applicable standards and regulations to ensure CMCF compliance with accrediting standards.

• BS/BA in Science, Medical Technology or related field required.
• 2 years of related quality assurance and cGMP experience and 1 year of laboratory experience in a related field (clinical laboratory, blood bank, cell processing, pharmaceutical industry).

• 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.
• Ability to communicate effectively with multiple internal departments and external business partners.
• Strong organizational skills and follow through.
• Ability to work independently with minimal supervision,…