JOB SUMMARY: Performs quality assurance oversight of cellular therapy product and vector manufacturing under the regulations of Good Manufacturing Practices. Reviews product manufacturing records for compliance and completeness; issues Certificates of Analysis; performs audit and assists in the preparation, review and maintenance of Standard Operating Procedures; ensures compliance with relevant Federal regulations; assists in the development and implementation of training programs and educational activities associated with quality assurance and control. Interacts with Federal, national and local agencies and institutions to represent quality assurance and manufacturing activities. Assists in the preparation of reports, publications and presentations associated with job functions. Assists with training and education of junior quality assurance and control staff members and with product manufacturing technologists.
ESSENTIAL FUNCTIONS AND DUTIES:
*Assists in quality assurance oversight of Good Manufacturing/Tissue Practices in Cellular Therapy and Vector Production Facilities;
*Ensures compliance with all applicable Federal regulations;
*Reviews documentation associated with manufacturing and facility activities;
*Performs audits and assists in the development of new quality assurance programs and activities;
*Interacts with federal, national, state and local authorities & agencies in relation to quality assurance and regulatory compliance;
*Prepares reports and other documentation relating to quality assurance and product manufacturing activities;
*Provides leadership, guidance and training to junior staff;
*Performs other job-related duties as assigned.
Required: Bachelor's degree in basic science or other relative scientific field.
Required: Five years of experience in quality assurance/control, preferably in the area of biologicals, pharmaceuticals and/or cellular therapies.
None required.
REQUIRED SKILLS AND ABILITIES:
*Sound interpersonal and interactive skills.
*Knowledge of FDA regulations.
*Ability to communicative effectively and clearly both orally and in writing.
*Strong organizational skills.
*Basic computer skills ? Knowledge of Word, Excel and other MS Office programs.
