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Quality Assurance Specialist I, Document Control and Training [Contract to Hire] at Iovance Biotherapeutics - ApplyBlast

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

Iovance Biotherapeutics

5 months ago

2.5 on Glassdoor

Remote

Full Time

Senior

0 applicants

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About this role

A Senior Quality Document Control and Training Specialist at Iovance Biotherapeutics responsible for managing and monitoring the processing, review, approval, archival, and distribution of revision-controlled documents in the Electronic Document Management System (eDMS). The role involves providing user support and guidance on document workflows, ensuring documents meet formatting and compliance standards, maintaining document records, coordinating periodic reviews, supporting internal and external inspections, and managing training assignments and reports.

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.

Skills

Qualifications

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.High level of attention to detailStrong computer, organizational, and compliance skillsFamiliarity with document change management and FDA quality systems

About Iovance Biotherapeutics

iovance.com

Headquarters

San Carlos, California, United States

Company Size

501-1000 employees

Founded

2007

View Profile

Iovance Biotherapeutics is a clinical-stage biopharmaceutical company developing tumor-infiltrating lymphocyte (TIL) therapies for solid tumors. Its lead product Amtagvi (lifileucel) is being investigated in multiple clinical trials, with manufacturing conducted at the Iovance Cell Therapy Center in Philadelphia, PA, and collaborations with academic and industry partners to advance next-generation TIL platforms.