Cell Manufacturing Quality Specialist

Overview

The Cell Manufacturing Quality Specialist III is responsible for managing the activities of multiple quality improvement and change management initiatives to ensure that systems are safe, effective, appropriate, compliant, current and adhered to by CMCF staff. The Cell Manufacturing Quality Specialist III understands and applies principles of quality management practices to the monitoring and improvement of CMCF operations.The Cell Manufacturing Quality Specialist III prepares for on-site surveys and audits. Collaborates with multidisciplinary teams for assigned initiatives.

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
• Competently perform and interpret data analysis and reporting / presentations
• Perform audits, compile findings and, suggest recommendations; if applicable, share with staff and management
• Participate in process improvement projects
• Competently perform deviation reviews
• Competently manage the oversight of internal CMCF audits and select external audits
• Competently participate in RCA (root cause analysis)/CAPA (corrective and preventative action plans)
• Independently perform review of validation plans and completed validations
• Manage the document control system by supporting multidisciplinary teams in developing controlled documents
• Suggest new areas to audit for possible improvements
• Train new QA staff and participates in onboarding as needed
• Maintain a good foundation knowledge of applicable standards and regulations to ensure CMCF compliance with accrediting standards
• Participate in the management of new trials prior to activation

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
• 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, including ability to escalate appropriately
• Ability to use critical thinking to recognize areas that need improvement and distinguish those that may impact patient safety
• Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment

MINIMUM JOB QUALIFICATIONS:

The position requires a BS/BA in science, medical technology, or a related field. Candidates must have at least 4 years of experience in quality assurance and cGMP, including 1 year of laboratory experience in a related field such as a clinical laboratory, blood bank, cell processing, or the pharmaceutical industry. Alternatively, 2 years of internal experience as a QA/QI Specialist II may meet the requirement.

SUPERVISORY RESPONSIBILITIES: None

PATIENT CONTACT: None

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 committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate 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 characteristics protected by law.

Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).