Technical Learning Specialist I, GMP Training Administration

About the role

Iovance Biotherapeutics is seeking a highly motivated GMP Training Administration Specialist I to support the Technical Learning program and ensure effective training implementation at the Cell Therapy Center (iCTC) in Philadelphia, PA. This role involves administering Iovance’s electronic Learning Management System (LMS), providing end-user support, and collaborating with cross-functional teams to develop competency-based curricula.

Responsibilities

• Support the right-first-time review of training documentation in the LMS and provide accurate ad hoc and scheduled training reports for functional groups and leadership.
• Maintain qualification training records for site personnel in the LMS and review Training Qualification Forms for approval, rejection, or implementation.
• Administer and assign training in the LMS, including creating new LMS infrastructure (courses, job codes, etc.).
• Support new hire onboarding by assigning training in the LMS and facilitating orientation.
• Support training checkpoints for new and revised documents, making simple decisions about training assignments with cross-functional guidance.
• Provide LMS end-user support and troubleshoot simple problems within the system.
• Work with cross-functional teams to develop competency and department-specific curricula.
• Deliver training sessions when applicable and ensure training documentation is maintained to meet company production and quality targets.
• Assist functional groups with the creation or improvement of training content for established processes.
• Support projects for new methodologies in LMS implementation and continuously seek improvements to training efficiency and efficacy.
• Adhere to GMP, SOPs, and GDP, including maintaining accurate records and documentation.
• Attend meetings and escalate issues or concerns to Area Management for further investigation.
• Lead meetings with area owners to drive training-related projects to closure.
• Contribute to department operations improvement, such as SOP revisions and department inspections.

Requirements

• Bachelor’s degree (Life Sciences preferred) and a minimum of 2 years of experience in training and documentation in a pharmaceutical or biopharmaceutical GMP-based facility; or an advanced degree without experience; or equivalent work experience.
• Familiarity with document change management and FDA quality systems.
• Experience with an LMS/DMS system (MasterControl is a plus).
• Strong right-first-time mentality, attention to detail, and proficiency in Word and Excel.
• Strong computer, organizational, and compliance skills with the ability to work on multiple projects simultaneously with minimal supervision.
• Excellent interpersonal and communication skills.

Physical Demands and Activities

• Ability to remain in a stationary position (standing or sitting) for prolonged periods.
• Ability to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.
• Visual acuity to perform activities such as preparing and analyzing data, viewing a computer screen, and extensive reading.
• Ability to perform repetitive motions involving the wrist, hands, and/or fingers.
• Ability to communicate effectively to exchange information.

Mental Requirements

• Clear and conceptual thinking ability with excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
• Ability to handle work-related stress, manage multiple priorities simultaneously, and meet deadlines.

Work Environment

This role operates in a professional office environment and a manufacturing lab setting, with potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical substances. Requires operating standard office equipment and keyboards.