Quality Assurance Specialist I, Document Control and Training [Contract to Hire]

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

This position is responsible for supporting the Quality Document Control and Training program and ensuring compliance to quality objectives and regulatory requirements.

Essential Functions and Responsibilities

• Independently manage and monitor the processing, review, approval, archival, and distribution of revision- controlled documents in the Electronic Document Management System (eDMS).
• Provide user support and guidance on document workflows, processes, and system usage.
• Ensure documents meet formatting, content, and compliance standards prior to approval.
• Maintain document records to ensure accuracy, completeness, and traceability within the system.
• Coordinate document periodic reviews of controlled documents to ensure ongoing accuracy and compliance.
• Support internal and external inspections by retrieving documentation and ensuring inspection readiness.
• Independently manage training assignments and task execution within the Electronic Document Management System (eDMS).
• Generate and distribute training compliance reports for management and audit purposes.
• Support onboarding training activities and assignment of required curriculum.
• Identify and escalate process inefficiencies within document control and training workflows.
• Perform miscellaneous duties as assigned.

Travel – none required

Required Education, Skills, and Knowledge

• Bachelor’s degree in Life Sciences discipline preferred, not required.
• Two (2) years in QA training and documentation in pharmaceutical or biopharmaceutical GMP based facility. Experience in other areas of Quality (Quality Operations and/or Quality Systems) is a plus.
• Must possess a high level of attention to detail and proficient in Word and
• Strong computer, organizational, and compliance skills
• Proficient in an eDMS/eLMS system (specifically MasterControl). Experience as MasterControl System Administrator or MasterControl Document Control Administrator is a plus.
• Familiarity with document change management and FDA quality systems
• Ability to work effectively on multiple projects simultaneously with minimun
• Strong interpersonal and communication skills

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required 

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment 

This job works in a home office space.  Requires operating standard office equipment and keyboards.

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