Summary

This position will manage and coordinate the day-to-day logistics operations regarding safety testing of investigational new drugs for patient treatments in compliance with FDA, IRB, FACT and ISCT directives. This role will also perform environmental monitoring of manufacturing facilities and in-house safety testing in compliance with FDA guidances.

Job Duties

• Develops and maintains standard operating procedures.
• Maintains the QA/QC program including but not limited to: equipment qualifications/validations, process validation, ensuring preventive maintenance schedules are maintained, and performing internal quality audits.
• Provides leadership, guidance, and training to junior staff.
• Performs quality control testing following standard operating procedures.
• Maintains accurate and complete documentation of work performed.
• Conducts procedures in compliance with all relevant guidelines in accordance with good laboratory practices regulations.
• Interprets results as designated by protocols to determine safety as related to the activities of the QA/QC Program.
• Participates in general laboratory duties including specimen handling, records management, and supply inventory.
• Manages Domestic and international shipments of clinical products to clients and hospitals for research and/or patient care.
• Handles inventory management of clinical products, particularly vectors to comply with FDA requirements; this involves both 80 degree C and LN2 freezers between the two facilities.
• Handles comprehensive maintenance and documentation of all Good Manufacturing Records such as: shipping records, equipment records, transfer of Clinical Products to Quality Control Laboratory or technical staff and Environmental Monitoring records.
• Is proficient in basic laboratory skills that can be expanded upon for training in current laboratory testing such as PCR and tissue culture assays.
• Has Knowledge of Good Manufacturing Practices and documentation.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Master's degree in a Basic Science or a related field.
• Proficient in basic laboratory skills.