QC Technical Trainer III

Role Overview

The QC Technical Trainer is an exempt level position working within QC Microbiology training team. This individual will be responsible for performing training activities for Quality Control Microbiology team members who support cGMP Clinical and Commercial Cell Therapy testing. This role will require technical experience, effective communication, coordination, and collaboration across relevant cross functional groups to enable robust testing and release of products to patients.

This position is primarily a M-F schedule, with potential nights or weekends temporary coverage as needed.

• Lead, coach, and deliver trainings for the Quality Control Microbiology team and Operations team (as needed).
• Be responsible for conducting training and qualifying QC Microbiology Specialists on QC test methods.
• Work closely with QC Onboarding Associate(s)/QC Leads/Supervisors to ensure planned training events were completed as scheduled and provide feedback as needed.
• Conduct Observation, Side-by-Side, and Instructor Led Training inside of laboratory and CAR-T cGMP Manufacturing facility.
• Conduct knowledge and skill check and independent performance qualifications for Quality Control Microbiology inside of laboratory and CAR-T cGMP Manufacturing facility.
• Ensure testing and training is completed in compliance with all applicable procedures, standards and GMP regulations.
• Support day to day Quality Control Microbiology activities as needed.
• Perform peer review/ approval of laboratory data as needed.
• Helps write or revise SOPs, Work Instructions, Job Aids, knowledge, and skills assessments.
• Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel.
• Work cross functionally with the training team to ensure the development/ qualification processes.
• Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution.
• Provide awareness trainings to the Quality Control Microbiology team.
• Performs trainings within CAR-T manufacturing facility inside of cleanroom environments.
• Serve as subject matter expert for Learning Management Systems.
• Support the maintenance and reporting of quality training metrics.
• Other duties will be assigned, as necessary.

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A Minimum of 0-2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience in a Quality Control setting is preferred.
• Experience with biosafety cabinets is required.
• Candidate must have experience working within an aseptic manufacturing facility, preferably within quality control, quality assurance, training/systems applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practices is required.
• Experience with training methodology, adult learning theory, and train-the-trainer programs.
• Curriculum and module design experience.
• Detailed knowledge of CAR-T QC test methods and related equipment is required.
• Excellent written and oral communication skill are required.
• Candidates must be able to accommodate occasional weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.
• This position may require up to 5% domestic or international travel as business demands.

The anticipated base pay range is: $81,273 USD - $106,669 USD

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package…