Qual. Control Supervisor, Flow Cytometry (52705)

  • Job Type: Full Time
  • FTE/Bi-Weekly Hours: 1.0/80
  • Shift: Days
  • Hours in Shift: 8
  • Location: Palo Alto, CA
  • Req: 52705

Job Description


Quality Control Supervisor, Flow Cytometry - CLS/Medical Technologist


Responsible for managing daily Quality Control operations within the Stanford BMT-Cellular Therapy Facility operated by the Blood & Marrow Transplant Program and providing technical supervision as necessary. Duties include but are not limited to coordinating the daily work assignments of the QC Analysts including night and weekend assignments. The supervisor maintains current knowledge of regulatory requirements pertaining to the QC testing of cellular therapy products in accordance with GTP and GMP requirements. In addition, the supervisor is responsible for the training of all subordinates in the facility's current policies and procedures, and assesses staff proficiency and compliance with quality control assays, and regulatory requirements used in the CTF. The technical supervisor interacts occasionally with the physicians, administrators and staff of the Blood and Marrow Transplantation Program, Stanford Health Care, and Stanford Childrens Health in order to coordinate the QC testing of of investigative cell therapy products. Although this is primarily a day-shift position, the supervisor must be accessible to CTF staff for consultation either on-site, by telephone, or by electronic means as needed. Participates in assessment and implementation of cell-based therapies and methodologies consistent with the facility's role.


Essential Functions




The essential functions listed are typical examples of work performed by positions in this job classification. They are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Employees may also perform other duties as assigned. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility entailed.


- Employees must abide by all Joint Commission requirements including, but not limited to, sensitivity to cultural diversity, patient care, patients' rights and ethical treatment, safety and security of physical environments, emergency management, teamwork, respect for others, participation in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and licensure and health screenings.


- Employees must perform all duties and responsibilities in accordance with the C-I-CARE Standards of the Hospital. C-I-CARE is the foundation of Stanford's patient-experience and represents a framework for patient-centered interactions.


C-I-CARE
- Executes world class practices of service and patient care in support of C-I-CARE standards.
- Uses C-I-CARE templates and the following components for all communication with patients and staff:
- CONNECT with people by calling them their proper name, or the name they prefer (Mr., Ms., Dr.)
- INTRODUCE yourself and your role
- COMMUNICATE what you are going to do, how long it will take, and how it will impact the patient
- ASK permission before entering a room, examining a patient or undertaking an activity
- RESPOND to patient's questions or requests promptly; anticipate patient needs
- EXIT courteously with an explanation of what will come next.


The supervisor's duties require technical proficiency in QC testing methodologies with a focus on flow cytometry as well as excellent organizational and interpersonal skills for the management of the QC Analysts. The supervisor plays an integral role in the successful operation of the laboratory, thereby contributing significantly to the overall success of the BMT program and investigative studies


The responsibilities of the supervisor include both technical and managerial aspects of laboratory operation for a QC group. Among these are:



- Supervision of the daily operations of the CTF employees classified as QC Analysist (I-III) (Flow Cytometry), as well as the support functions provided by the Laboratory and Office Assistants. The Supervisor provides oversight and instruction to individual employees on both work and administrative matters. The Supervisor also participates in the hiring, promotion or reassignment of subordinates; resolves employee complaints or refers them to the level at which the complaints can be resolved; recommends disciplinary measures including warnings, reprimands and suspensions; and identifies developmental needs and coordinates the appropriate training.


- Provides technical expertise in QC procedures with an emphasis on flow cytometry by maintaining current knowledge of the technical and regulatory aspects of Quality Control in accordance with GTP and GMP as appropriate (FACT, CFR 1271, 210 & 211, USP, EP, ICH, etc.). Attendance, and participation in, at least one relevant conference annually is expected including presentations and/or advisory committee involvement.


- Establishment of daily work schedules for the laboratory staff such that:
All quality control procedures are accomplished in a timely manner with adherence to approved SOPs and regulatory requirements;
The QC laboratory is organized, maintained and documented as per regulatory requirements;
Assignment schedules are prioritized in accordance with patient and product requirements;
Assignments result in an equitable distribution of the work load allowing each QC Analyst to frequently perform all QC related procedures.
The QC laboratory is maintained in a state of operational readiness in accordance with approved policies and procedures


- Maintenance of standard operating procedures (SOPs) for all QC operations for compliance with current Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP), as appropriate, and to participate in the review and revision of SOPs annually in order to meet current standards of operation for QC laboratories as defined by relevant accrediting and regulatory agencies.
- Communicate procedural deviations, errors, and unexpected events to the laboratory director and to the quality personnel in a timely manner.
- Oversees new SOP, process and assay development, as required, in support of new procedures adopted by the QC team, either internally or at client request. Oversees document and process updates of existing procedures
- Oversees the validation and implementation of QC procedures and test methods, as directed.
- Communicates and collaborates with hospital and university staff, vendor representatives, and outside contractors, as necessary, to assure operational readiness of the QC facility and completion of assigned duties. Actively manage team activities and resource plans related to the implementation of QC activities to support the onboarding and implementation of multiple simultaneous investigational studies.


Additional duties and responsibilities of the QC Supervisor include:


- Training new personnel and assessing existing personnel in the policies and procedures of the CTF with supportive documentation of competency in each aspect of training and to update the knowledge of the CTF QC staff regarding changes in methodologies, policies, and procedures.


- Participating in the recruitment, interviewing and selection of new laboratory personnel and making recommendations regarding the subordinate promotions and disciplinary measures.


- Providing back-up and support for QC activities as workload and staffing demands including sharing the on-call duties for after-hours and weekend processing


- Development and implementation of QC procedures and test methods.


- Assessing equipment, supply and space requirements for QC operations and to recommend purchasing of equipment, supplies, and services necessary to meet cell processing objectives.


- Overseeing both routine and unscheduled maintenance of equipment, housekeeping and environmental monitoring.


- Assisting with QC staff performance evaluations by observation of employee bench work, staff interactions, and thoroughness in meeting QA-QC objectives and to communicate regularly with the facility director regarding personnel issues.


- Assuring that all QC staff, lab and office assistants are working in compliance with applicable personal safety guidelines

Equal Opportunity Employer Stanford Health Care (SHC) strongly values diversity and is committed to equal opportunity and non-discrimination in all of its policies and practices, including the area of employment. Accordingly, SHC does not discriminate against any person on the basis of race, color, sex, sexual orientation or gender identity and/or expression, religion, age, national or ethnic origin, political beliefs, marital status, medical condition, genetic information, veteran status, or disability, or the perception of any of the above. People of all genders, members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply. Qualified applicants with criminal convictions will be considered after an individualized assessment of the conviction and the job requirements.

Qualifications



- Bachelor's degree in a clinical or life science-related discipline/field from an accredited college or university


- MORE THANS FOUR (4) YEARS OF QC EXPEREINCE, WITH AN EMPHASIS ON FLOW CYTOMETRY IN A REGULATED ENVIRONMENT


- ONE (1) YEAR OF LEAD TECH/SENIOR TECH/SUPERVISOR/MANAGER EXPERIENCE


- Previous experience running multi (up to 12)-color flow cytometry on blood-derived cell types or familiarity with BD-FACS Lyric/Canto flow cytometer or similar preferred


- applicants are encouraged to hold a Current Medical Technologist certification with American Society of Clinical Pathologists (ASCP), Clinical Laboratory Scientist or Clinical Immunohematologist Scientist license with California Department of Public Health within six (6) months of hire and is highly desired



KNOWLEDGE, SKILLS and ABILITIES


- Ability to supervise a team of staff in a fast paced and ever changing environment
- Ability to follow complex written and oral instructions of high complexity in English.
- Actively participates in and completes continuing education and demonstrate proficiencies related to QC and Flow Cytometry and commensurate with assigned duties
- Ability to speak and write and revise documents of high complexity in English
- Highly proficient in computer systems and software used in functional area (MS Word, Excel, PowerPoint, databases, FACS Diva, FACS Suite).
- Ability to multitask and drive logistics in fast paced environment
- Ability to perform detailed work on a consistent basis
- Ability to communicate effectively with a high skill level
- Ability to plan, organize and prioritize their own work and the team, work independently and meet deadlines
- Ability to work effectively with individuals at all levels of the organization
- Ability to perform and oversee QC testing of blood/cell therapy products for patient care purposes.
- Ability to independently identify and understand problems/issues of a complex nature and drive to resolution in a fast paced and high pressure environment.
- Ability to interpret and synthesize results from a wide variety of tests correctly and quickly.
- Ability to perform mathematical calculations and complete detailed documentation with accuracy.
- Ability to fulfill continuing education requirements and demonstrate proficiencies related to cell processing and commensurate with assigned duties.
- Knowledge of Good Laboratory Practices (GLP), Good Tissue Practices (GTP) and/or Good Manufacturing Practices (GMP) as applied to cellular therapeutics.
- Knowledge of Medical Terminology



Our Mission: To Care, To Educate, To Discover
Our Vision for the SHC Experience: Healing humanity through science and compassion, one patient at a time

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