Job Description

Overview

The Cell Processing Quality Control Specialist I trains and becomes competent at performing, interpreting and reporting for quality control assays required for cellular product evaluation. Responsible for the quality control (QC) of reagents, supplies, facility environmental testing, laboratory equipment maintenance and QC performed in the Cell Manipulation Core Facility.  The Cell Processing Quality Control Specialist I is responsible for QC procedures that are performed under the highest standards of quality in a timely manner while minimizing costs.

Shift is 12:30pm-9pm. Flexibility with work schedule based on lab needs is required.

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.

Responsibilities

Technical Duties and Responsibilities:

• Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records.
• Accurately perform, analyze and demonstrate proficiency of the following tests at a minimum:
• automated and manual cell counts, including trypan blue viability testing,
• basic flow cytometry analysis (CD34, T subsets, 7AAD viability, etc.),
• potency assays such as CFUs, etc.,
• basic microbiology cultures and gram stains (clinical and environmental).
• Must interpret QC and test results, trends and respond/report according to procedure and policy.
• Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and all maintenance performed.
• Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
• Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications. Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify the senior specialist or supervisor.
• Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
• Follow regulations (FDA, CLIA, HIPAA, OSHA, state), standards (FACT, JC) and safety guidelines.
• If applicable, answer questions from clinicians or other lab personnel.
• Maintain complete records of all testing performed.
• Maintain general clean and organized appearance of the department.
• Ensure reagents/test kits have received dates, expiration dates, and if applicable, opened dates.
• Attend monthly department and any additional training/educational meetings.
• Participate in all applicable safety training sessions. Know the location and contents of the safety manual.  Know the location/use of all applicable safety equipment.
• If needed, participate in government or regulatory agency inspections.

Qualifications

Minimum Education requirement:

• Associate degree in chemical, physical or biological science or medical laboratory required.

Minimum Experience requirement:

• Entry level in for cellular product high complexity testing lab.
• Must qualify as Testing Personnel under CLIA as independent judgment is required for the high complexity work performed in the following areas: hematology, immunology, microbiology, and molecular biology.
• Experience in a clinical laboratory performing high complexity testing (may have been a part of an internship program).

Preferred Qualification: 

• Bachelor's degree in medical technology, clinical laboratory, chemical, physical or biological preferred.
• MT (ASCP) certification or International Cytometry Certification Exam (ICCE) or other laboratory certification preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Basic knowledge of general clinical laboratory practices, hematology and microbiology. In addition, must demonstrate general lab skills, aseptic practices, knowledge of lab safety and infection control practices.
• Able to perform aseptic processing of samples for relevant tests.
• Ability to accurately perform simple laboratory math calculations.
• Ability to work closely with others, possess solid interpersonal and communication skills.
• Capable of working in a fast-paced environment; effective in a diverse work group; willing to work in a rapidly changing work unit.
• Capable of handling stress of producing accurate results under time constraints.
• Good judgment, problem solving and analytical skills.
• Requires attention to detail and interpersonal skills to effectively communicate with both laboratory and clinical staff within a complex, multi-organization environment.

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 characteristics protected by law.

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