Cell Manufacturing Quality Specialist I

Job Details

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Job ID:
24079

Location:
450 Brookline Ave, Boston, MA 02215

Category:
Medical Technologist

Employment Type:
Full time

Overview

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 Cell Manipulaltion Core Facility (CMCF) staff.  The Cell Manufacturing Quality Specialist I builds understanding of quality management practices to the monitoring and improvement of CMCF operations.

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 underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Requirements

PRIMARY DUTIES AND RESPONSIBILITIES:

  1. Perform established batch record review, assess completeness and accuracy in conjunction with expected outcome with assistance as needed.
  2. Perform selected data analysis and reporting with assistance.
  3. Assist with audits.
  4. Assist with process improvement projects.
  5. 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.

Qualifications

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.

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.

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