QC Specialist - Flow Cytometry (Cell Therapy)

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This is a Stanford Health Care job.

A Brief Overview
Stanford BMT-Cellular Therapy Facility, operated by the Blood & Marrow Transplant Program, is currently seeking a QC Specialist to perform flow cytometry for our Quality Control team. The successful candidate will be responsible for oversight and performing routine high complexity quality control product and raw material release testing utilizing multi (up to 12)-color flow cytometry as well as various biochemistry, molecular biology, and general laboratory techniques according to GMP. Additionally, the QC Specialist participates in development and implementation of flow cytometry assays and oversees with technology transfer of new client assays by authoring SOPs or other required documentation and assisting other QC Analysts. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

Locations
Stanford Health Care

What you will do

• Performs routine in-process and final release assessments of products using multi (up to 12)-color flow cytometry
• Oversees the compiles all documentation for inclusion in paper and electronic QC records and reviews data for compliance and product release
• Oversees the efficient workflow of all required testing and documentation ensuring timely submission relative to product release dates
• Reviews and analyses entered assay results into the appropriate trending databases for periodic analysis
• Coordinates scheduling, and acts as back up for management in overseeing the master schedule and assists the QC Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Oversees familiarity with QC-relevant cGMP guidance’s (FACT, CFR 1271, 210 & 211, USP, EP, ICH, etc.)
• Assists in 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 implementation of quality improvement initiatives for QC laboratory operations
• Oversees in laboratory, OOS, CAPA or other investigations, as required
• Manages laboratory supplies, media and reagents inventory
• Oversees and adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Responsible for management of the routine laboratory upkeep and organization
• Scheduled on-call and weekend work is required with flexibility to extend working hours as needed
• Trains junior staff on medium/high complexity procedures

Education Qualifications

• Bachelor's Degree BACHELOR'S DEGREE IN A CLINICAL OR LIFE SCIENCE-RELATED DISCIPLINE/FIELD FROM AN ACCREDITED COLLEGE OR UNIVERSITY.

Experience Qualifications

• More than Five (5) years of experience in QC and/or flow cytometry.

Required Knowledge, Skills and Abilities

• Demonstrated knowledge in “core” laboratory techniques (e.g. ELISA, cell culture/counting, PCR, etc.) and modeling a high level of aseptic technique
• Ability to follow written and oral instructions and procedures of high complexity in English.
• Actively participates in and completes continuing education and demonstrate proficiencies related to cell processing and commensurate with assigned duties.
• Ability to speak and write and revise documents of high complexity in English
• Ability to work independently in process development and regulatory compliance
• Ability to independently troubleshoot and solve problems of high complexity
• Ability to function independently, as a team member and team leader
• Ability to perform complex mathematical calculations
• Attention to detail and documentation
• Highly proficient in computer systems and software used in functional area (MS Word, Excel, PowerPoint, databases, FACS Diva, FACS Suite).
• Working Knowledge of Medical Terminology, scientific concepts and practices.
• Working Knowledge of Good Tissue Practices (GTP) and/or Good Manufacturing Practices (GMP) as applied to cell therapies
• Willingness to cross-train in other areas within the facility
• High level proficiency in aseptic technique, cell processing of moderate complexity and cryopreservation

These principles apply to ALL employees:

SHC Commitment to Providing an Exceptional Patient & Family Experience

Stanford Health Care sets a high standard for delivering value and an exceptional experience for our patients and families. Candidates for employment and existing employees must adopt and execute C-I-CARE standards for all of patients, families and towards each other. C-I-CARE is the foundation of Stanford’s patient-experience and represents a framework for patient-centered interactions. Simply put, we do what it takes to enable and empower patients and families to focus on health, healing and recovery.

You will do this by executing against our three experience pillars, from the patient and family’s perspective:

• Know Me: Anticipate my needs and status to deliver effective care
• Show Me the Way: Guide and prompt my actions to arrive at better outcomes and better health
• Coordinate for Me: Own the complexity of my care through coordination

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.