5-7 years experience in cell processing and quality assurance
Strong knowledge of regulatory standards (FACT, FDA, JCAHO, AABB)
Experience in auditing and compliance monitoring
Skilled in data analysis using databases and spreadsheets
Excellent communication and interpersonal skills
Ability to manage multiple tasks in a fast-paced environment
Problem-solving and analytical skills with a keen attention to detail
Responsibilities
Conduct internal audits to ensure compliance with industry standards
Update the Quality Program for various cell therapies according to regulations
Assist in regulatory interactions and submissions, including INDs
Lead quality improvement processes within the laboratory
Document and report on deviations and quality control issues
Provide training and education for laboratory personnel on policies
Participate in validation processes for new instruments and methods
Benefits
Professional development and continuous education opportunities
Involvement in industry meetings and conferences
Access to a collaborative laboratory environment
Potential for involvement in cutting-edge research
Support for work-life balance with flexible scheduling options
Full Job Description
Must have a working knowledgeable of basic and complex principles and practices of cell processing and experience as an auditor and compliance specialist. The QA/QI Specialist is responsible assisting in the monitoring for quality to ensure that systems are appropriate, current and being adhered to by all staff of the Cell Manipulation Core Facility. This position requires the individual to be actively engaged in the field by teaching, managing and advancing the field by participation in professional meetings, publications or presentations.
Be knowledgeable with all requirements of regulatory and accreditation agencies to include: FACT, FDA, JCAHO, AABB, CLIA, DOT, DPH and OSHA
Perform and report on internal audits and assessments of laboratory processes to ensure compliance with JCAHO, AABB and FACT standards and FDA regulations and outside sponsor audits
Responsible to work with the manager to update the Quality Program for hematopoietic progenitor cells, therapeutic cells and other cell processing according to regulatory and accrediting organization requirements
Assist QA Manager in interactions with industry and government to include IND submissions, FDA registration or licensure, etc.
Prepare and participate in inspections and compliance audits
Leading and facilitating various quality processes (RCA, CAPA, Lean, and FMEA) to improve the department and report on laboratory's performance. Participate in continuous improvement activities
Manager the laboratory Episode/Deviation Log, track and analyze deviations for undesirable trends and propose methods of quality improvement. This includes reporting on errors, deviations, OOS (out of specifications) and adverse events and working with various teams to propose improvement opportunities
Manage and report data for evaluation of clinical outcomes to include reviewing, compiling, and performing trend analysis of engraftment, bone marrow harvest quality and infusional toxicities data
Review manufacturing and quality control records. Document deviations / omissions and initiate corrective action and documentation of these actions
Manage periodic review of assigned laboratory manuals, maintenance of archive files and maintenance of files of any other pertinent documentation for new or revised policies and procedures
Manage continuing education program for laboratory personnel on relevant aspects of CMCF policies, procedures and the Quality Program.
Assist in development of policies and procedures for product testing and release and perform such testing. Provide training on procedures for CMCF laboratory personnel
Development training modules and provide training in areas of subject matter expertise
Work within the cGMP and cGTP guidelines and adheres to all regulatory standards within the Cell Manipulation Core Facility. Prepares and implement modules for GMP /GTP training
Train CMCF members and others on safety program and clean room procedures well as emergency preparedness, chemical, infectious agents and radioactive hazards
Maintain the continuing education records for laboratory employees.
Verify that staff members adhere to department and section procedures and processes
Assist in the development, implementation, monitoring of databases (engraftment, reactions, BOE, etc.) and information systems used in the department. Recommend audits for assessing performance of said databases
Performs other duties as assigned
Perform pre and post processing review of batch records to assess compliance with clinical trial requirements
Serves an independent auditor and verifier for assigned clinical trial procedures and processes
Performs QC, QA and laboratory duties based on expertise
Participate in validation of new instruments & methods
Maintains records of procedures and resultant data, both manually and on computer
Must be proficient in working with computer data bases & spreadsheets to extract and analyze data and maintain data from corruptions.
Other general administrative and laboratory duties as required
Participate as a CMCF representative /member at DFCI/BWH/BCH committees such as safety, Infection Control, etc.
Evaluates new procedures, supplies, equipment and clinical trials for unique attributes and requirements and brings forth recommendation to CMCF leadership
Use resources (supplies, time, and people) in a responsible cost-effective manner
Organize and prioritize multiple technical tasks with max efficiency and minimal waste
Position requires an ongoing commitment to upgrading of job skills. Must be able 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 on off-shifts, capable of handling stress of producing accurate results under time constraints; willing to accommodate schedule adjustments, as well as off-shift and weekend assignments as workload dictates
Must possess good judgment, problem solving and analytical skills.
Experience with operation & troubleshooting of lab instrumentation and assay systems is desirable
The ability to be flexible & adaptable to changing technology.
Ability to use a wide variety of analytical techniques and instrumentation
Requires attention to detail and interpersonal skills to effectively communicate with staff and physicians
Adherence to practices for aseptic technique
Is required to use good analytical reasoning and apply advance statistical methods for analyzing data
General lab skills and knowledge of lab safety and infection control.
Knowledge & understanding of the policies & procedures of the lab.
Knowledge of the lab equipment and ability to interact with patients, employees and management
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).
$98,500.00 - $109,100.00
About Dana-Farber Cancer Institute
Dana-Farber Cancer Institute is a non-profit organization that provides cancer treatment and research services. The institute was founded in 1947 and is affiliated with Harvard Medical School. Dana-Farber Cancer Institute is committed to providing the highest quality care to cancer patients, and is dedicated to finding new treatments and cures for the disease. The institute offers a range of services, including chemotherapy, radiation therapy, and surgery. Dana-Farber Cancer Institute is also involved in a number of research initiatives, and has made significant contributions to the field of cancer research.
