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Aseptic Trainer

Edison-New Brunswick Metro Area, NJ

Posted: 08/28/2019 Job Type: Scientific Job Number: JN -082019-25519

This role is responsible for the maintenance and delivery of Aseptic-training programs associated with the entire Cell and Gene Therapy Organization (CG&T) manufacturing program.


Skills:

Foster & support a team culture that is engaged and empowered Deliver instructor-led and on-the-job training associated with Quality Systems, GMP Training requirements Coach and train Cell Processing Specialist (CPS) OpQuals and Cell Processing Associate (CPA) OpQuals to trainees on the required skills and materials to perform their jobs aseptically and efficiently Maintain and support the scheduling of training activities including delivery of required training for specific portions of the manufacturing process (e.g. classroom instruction, hands-on training, etc.) Maintain the training program in accordance with business needs, regulatory requirements, and Quality Management System Continuously evaluate and provide improvements to the Aseptic/Technical training program Oversee and maintain training equipment, material and training environment Comply with site training requirements Provides the necessary training and support to new associates joining the organization Performs other training activities as requested


Assist in the development and / or review developed training materials for technical accuracy, regulatory compliance, and effectiveness Support the development of new CPS and CPA OpQuals trainers Demonstrate strong Aseptic Technique Support investigations and CAPAs related to process within required timelines Maintain processes to be inspection ready.

Provide training regarding best practices, technical transfers, and other trainings as needed to the manufacturing, quality, warehouse, support, site management


Education: Bachelor's degree in a scientific field with 2 - 5 years of GMP /pharmaceutical work experience or 1 - 3 years of Aseptic clean room experience.

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