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The Cell Processing Quality Control Specialist III is responsible for performing, interpreting and reporting of complex quality control assays required for the evaluation of cellular and gene manipulated products in a good laboratory practice environment ( 21 CFR Part 58 ). Responsible for the quality control (QC) of reagents, supplies, facility environmental testing, laboratory equipment maintenance and QC performed in the Cell Manipulation Core Facility. Specifically, this position will require specific attention to the validation and performance of highly complex assays such as molecular testing (nucleic acids and protein) and flow cytometry analysis of more-than-minimally manipulated / genetically modified cellular products. The Cell Processing Quality Control Specialist III is responsible for QC procedures that are performed under the highest standards of quality in a timely manner while minimizing costs.

Schedule: Monday - Friday, 40 hours per week.

On-call rotation 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.

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.)

• complex flow cytometry analysis for clinical trials

• assist Cell Processing Quality Control Lead Specialist/Supervisor/Manager in validation of assays and/or new methods

• potency assays such as CFUs, etc.

• basic microbiology cultures and gram stains (clinical and environmental)

• basic molecular biology assays including DNA and RNA PCR/Q-PCR/dPCR as well as protein immunoblotting

• Must review/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.

• Must have working knowledge of using information systems and databases to communicate and capture results.

• 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.

• Responsible for training new staff and demonstrating appropriate leadership skills within the department and within the Harvard Cancer Care network.

• Review and train on new procedures.

• 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.

• Able to appropriately troubleshoot instrument issues and test systems. Take the initiative to correct problems when issues/problems are identified.

• As appropriate, notify clinical staff of significant findings if test system deviates from the laboratory’s established performance specifications.

• Prepare training materials and competency assessment tools under the direction of the Supervisor.

• Takes the lead in areas of expertise and assists the Supervisor in other areas to ensure that the department is always inspection ready for a given area of relevant standards and regulations.

• Works with Supervisor to monitor daily activities and assists others in the lab on a regular basis.

• Assists Supervisor in review of records as required.

• Takes the lead in implementing a new method or installation of new equipment following all the regulatory requirements.

• Continues to enhance the field of cellular therapy by actively participating in relevant organizations by serving on committees, writing articles or presenting.

SUPERVISORY RESPONSIBILITIES:

• No direct reports, but is responsible for training, mentoring and providing work direction to other staff. Must qualify as a General Supervisor under CLIA-88.

• Minimum Education requirement:

• Bachelor's degree in medical technology, clinical laboratory, chemical, physical, or biological is required.

• Additional training in molecular biology, immunology or Flow Cytometry desired along with certification in a given discipline.Minimum Experience requirement:

• In addition to the qualifications for a Cell Processing Quality Control Specialist II, must have a minimum of 2 years of experience in a high complexity clinical laboratory setting.

• Must meet the qualification of a General Supervisor under CLIA-88. Certification/Registration:

• MT (ASCP) certification or International Cytometry Certification Exam (ICCE) or other laboratory certification preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Strong knowledge of general clinical laboratory practices, hematology, flow cytometry, molecular assays, immunohematology, and microbiology in cell therapy field is preferred. 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.

• Must be competent in performing routine assays

• 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.

• Able to work independently, capable of handling stress of producing accurate results under time constraints.

• Strong judgment, problem solving and analytical skills.

• Demonstrate successful project management skills by managing competing tasks/projects.

• Requires attention to detail and interpersonal skills to effectively communicate with both laboratory and clinical staff within a complex, multi-organization environment.

• Must have good technical and teaching skills, able to make sound judgments, good problem solving and analytical skills.

• Must have demonstrated increased working knowledge in a relevant area and can become a subject matter expert for the department in that area.

• Must have strong understanding of standards and regulations that govern the field, actively participating in relevant organizations, by serving on committees, writing articles or presenting on relevant subject matter.

• Able to provide direction to Cell Therapy Quality Control Specialist I and II.

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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