Quality Assurance Specialist I, Document Control and Training

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🕒 May 20

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions.