Apply for Vacancy for GMP Assistant at Weill Cornell Medicine in the USA. The category of the job is Laboratory and Research.
Responsible for facilitating the GMP production activities by providing all necessary elements (i.e., materials, equipment, document and facility) to the GMP Gene Therapy Production Technicians.
- Handles inventory, ordering, receipt, inspection and documentation of materials used in the GMP facility.
- Drafts and revises all quality control documents pertaining to material control to ensure a current and efficient material control system.
- Also, contacts vendors for technical support and with inquiries for new materials or obtaining Certificates of Analysis/Quality/Compliance, as well as the Material Safety Data Sheets.
- Likewise, tracks the inventory of released gene therapy products, cell and virus banks, in-process products and retention samples and maintains the inventory logs.
- Monitors Datatron and equipment in the GMP facility on a daily basis to ensure that the parameters of equipment and production rooms are within specification. Coordinates with the Facility Coordinator for periodical maintenance and repair, if necessary.
- Prepares Production Data Records (PDRs) and distributes to the GMP Gene Therapy Production Technicians. Maintains executed PDRs and ensures the PDRs are reviewed by the QA in a timely manner.
- Furthermore, tracks the sanitization schedule of the GMP facility, schedules the sanitization based on the production schedule, and leads the sanitization activity. Completes and maintains the sanitization records.
- Performs Equipment Qualification (EQ). Performs routine environment monitoring.
- Additionally, trained for the GMP production process to work as a back-up production technician.
- Attends GMP meetings and training programs and other institutional meetings and training programs. Keeps abreast of new developments in laboratory products.
- Similarly, performs other related duties as assigned.
Prior related experience.
Knowledge, Skills and Abilities
- Excellent communication skills (both verbal and written).
- Also, demonstrated organizational skills and ability to pay close attention to detail.
- Additionally, ability to meet multiple deadlines and handle multiple priorities.