Quality Control Specialist - Cell Based Therapy Laboratory

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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 talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage candidates of all races, colors, ethnicities, religions, perspectives, sexes, backgrounds, and lived experiences to apply.

A Brief Overview
The Quality Control Specialist is responsible for the quality control (QC) of materials, equipment and cell therapy products. This role ensures the accuracy, consistency, and compliance with regulatory standards to support high-quality and reliable test results at the Children's Hospital of Philadelphia. This includes conducting quality control tests, maintaining compliance with standards and internal policies, and implementing corrective actions when necessary. The QC Specialist works closely with laboratory staff to ensure the highest level of patient care and safety. All employees are responsible for compliance with written policies and procedures and for correctness, truthfulness, timeliness, legibility, integrity, and accuracy when recording data and observations in compliance with regulatory bodies such as the FDA, CAP (College of American Pathologists), and FACT (Foundation for the Accreditation of Cellular Therapy).

What you will do

• Performs QC assays commensurate with training and experience:
  • Conducts routine QC testing for cell therapy products, including in-process, release, and stability testing. Ensures timely turnaround time from sample submission to reporting of assay results
  • Performs basic maintenance, QC and calibration of laboratory instruments. Coordinates regular maintenance and calibration of laboratory equipment
  • Manages reagents QC lot release testing.
• Quality Management
  • Initiates change requests, incident reports and planned deviations. Assists in identifying and resolving issues and implement corrective and preventive actions.
  • Perform QC assay during qualification and validation of new processes
  • Drafts SOPs and work instructions
  • Supports audits by preparing necessary documentation and presenting findings.
  • Provides training to laboratory staff on quality control practices, equipment usage, and compliance standards.
• Analytical Method Development and Validation
  • Assists in developing, qualifying, validating, and troubleshooting of new analytical methods for cell and gene therapy products.
  • Performs biological and molecular assays needed for the development of characterization and release assays.
• Performs other duties as assigned

Education Qualifications

• Bachelor's Degree - Required
• Master's Degree - Preferred

Licenses and Certifications

• American Society for Clinical Pathology (ASCP) Certification - American Society for Clinical Pathology - upon hire - Preferred

Experience Qualifications

• At least one (1) year quality control experience. Required
• At least three (3) years quality control experience Preferred
• At least three (3) years in cGMP/GLP (or other regulated) environment. Preferred
• At least two (2) years experience in flow cytometry analysis and hematology analysis Preferred

Skills and Abilities

• Demonstrated ability to prioritize work, strong organizational and documentation skills and initiative to improve processes. (Required proficiency)
• Change agent demeanor. Must be a flexible thinker, with an ability to quickly adapt to a rapidly changing environment. (Required proficiency)
• Team-oriented, self-starting individual with good communication skills. (Required proficiency)

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, professionals working onsite-at any CHOP location, for any portion of time-must be vaccinated for COVID-19. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.