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
