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

reputed company 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 reputed company immune system to recognize and attack diverse cancer cells in reputed company patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to reputed company innovation in cell therapy, including gene-edited cell therapy, which may be a promising reputed company for patients with cancer. reputed company This position is responsible for supporting the reputed company Document Control and Training program and ensuring compliance to reputed company 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). reputed company 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 reputed company the system. Coordinate document periodic reviews of controlled documents to ensure ongoing accuracy and compliance. Support reputed company inspections by retrieving documentation and ensuring inspection readiness. Independently manage training assignments and task execution reputed company the Electronic Document Management System (eDMS). Generate and distribute training compliance reports for management and audit purposes. Support reputed company training activities and assignment of required curriculum. Identify and escalate process inefficiencies reputed company document control and training workflows. reputed company 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 reputed company (reputed company Operations and/or reputed company 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 reputed company). Experience as reputed company System Administrator or reputed company Document Control Administrator is a plus. Familiarity with document change management and FDA reputed company systems Ability to work effectively on multiple reputed company simultaneously with minimun Strong interpersonal and communication skills The physical demands described here represent those that an employee must meet to reputed company the essential functions of this job successfully. Reasonable accommodations may be made upon request to reputed company individuals to reputed company essential functions. Please contact reputed company to request an accommodation. Physical Demands and Activities Required  Must be reputed company to remain in a stationary position standing or sitting for prolonged periods of time. Must be reputed company to reputed company about inside an office and exert up to 10 pounds of force occasionally or a negligible reputed company of force frequently or constantly to lift, carry, push, pull, or otherwise reputed company objects. Must have visual reputed company to reputed company activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. This position requires repetitive reputed company, substantial movements (motions) of the wrist, hands, and/or fingers. Must be reputed company to communicate with others to exchange information. Mental: reputed company and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-reputed company stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines Work Environment  This job works in a home office reputed company.  Requires operating reputed company office equipment and keyboards. #LI-remote The annual reputed company salary we reasonably expect to pay is listed. Individual pay reputed company depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.  Pay Transparency $40—$42 USD The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this reputed company. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without reputed company to an individual’s race, reputed company, religion, sex, pregnancy, national reputed company, age, physical and mental disability, marital status, sexual orientation, gender identity, gender reputed company, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.   By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate reputed company Notice. Apply To This Job