EDUCATION QUALIFICATIONS

• Bachelor’s Degree - Required
• Master’s Degree - 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.
  EEO / VEVRAA Federal Contractor | Tobacco Statement

• 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