Cell Based Therapy Laboratory Quality Specialist

SHIFT:

Seeking Breakthrough Makers

Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

CHOP's Commitment to Diversity, Equity, and Inclusion

CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

A Brief Overview
The Cell and Gene Therapy Lab Quality Specialist will support and ensure quality assurance in all aspects of operation for the Cell and Gene Therapy Laboratory. Working with the Quality Manager, Lab Manager/Supv and Cell Therapy Specialists, s/he will ensure compliance with regulatory requirements for FDA, FACT, and CAP. Under the direction of the Quality Manager, collaborating with the Facility Directors and Lab Leaders, s/he will help guide the lab's strategic and operational planning towards Good Manufacturing Practices (GMPs) and Good Tissue Practices (GTPs).

What you will do

• In collaboration with the Quality Manager, perform scheduled and focused audits of lab processes and cross -functional systems, including but not limited to, training, document control, equipment management and validation, reagent/supply management and external vendors/suppliers. Develop audit plans/checklists and generate reports detailing findings for submission to operational management.
• Perform final release of cell therapy products
• Review validation plans and reports for equipment, assays, manufacturing processes, etc
• Assist with review of new or revised standard operating procedures (SOPs), labels and other controlled documents
• Review events/deviations, complaints, and adverse events. Ensure adequate corrective actions have been performed and deemed effective. Foster a fair and just culture through interactions with staff associated with nonconforming events
• Review monthly facility and equipment control parameters
• Review and maintain environmental monitoring results
• Participate in all Continuous Quality Improvement (CQI) activities. Assist in preparation of quality management reports for the monthly Clinical Laboratory CQI meeting, quarterly Cellular Therapy and Transplant (CTTS) quality meeting and annual report
• Support document control activities of SOPs, policies, labels, forms, etc. Ensure all electronic documents available to staff are current and obsolete documentation is properly archived
• Help with reviewing and maintaining the lab's Quality Management Plan and the annual audit schedule
• Assist in hosting internal/external audits/inspections
• Be proactive in making suggestions/recommendations to improve compliance and quality management activities
• Complete assigned tasks/projects as required by the quality manager

Education Qualifications

• Bachelor's Degree in physical science, applied science, biological science, medical technology, or other health related field - Required
• Master's Degree in biological science, medical technology, or other health related field - Preferred

Experience Qualifications

• At least three (3) years in the fields of cellular therapy, pharmaceutical biologics/drugs, healthcare Required and
• FDA regulations GTP/GMP, FACT, CAP (AABB optional) Preferred and
• Quality management, quality improvement, quality assurance, compliance Preferred
• Formal training in auditing Preferred
• Formal training in lean six sigma, with experience in lean six sigma methodologies and knowledge of and/or experience in data management (tracking, trending, and statistical process control analysis) Preferred

Skills and Abilities

• Experience applying data analysis to drive fact-based decisions (Required proficiency)
• Excellent communication skills, both verbal and written; adept at handling difficult conversations with lab staff, clinicians and physicians to meet established quality standards (Required proficiency)
• Ability to work both independently and in a team environment, take initiative when necessary and maintain confidentiality (Required proficiency)
• Ability to develop and maintain effective relationships and work collaboratively (Required proficiency)
• Teaching/coaching skills are required (Required proficiency)
• Ability to manage multiple projects and implement problem-solving capabilities (Required proficiency)

Licenses and Certifications

• Certified Quality Auditor (CQA). - American Society for Quality (ASQ) - upon hire - Preferred
• Lean Six Sigma Green Belt (LSSGB) - American Society for Quality (ASQ) - upon hire - Preferred

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

EEO / VEVRAA Federal Contractor | Tobacco Statement