Clinical QA Specialist II – Clinical Specialist Providers

Job not on LinkedIn

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $110k - $120k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• Maintain CSP qualification/requalification and oversight programs • Complete service provider qualification/requalification activities for CROs, laboratories, imaging services, ethics committees, computer systems/software, and other CSPs • Identify and mitigate risks for clinical service providers • Provide CQA oversight, including managing quality events, non-compliances, CAPAs, serious breaches, and CSP corrective action requests • Negotiate quality agreements • Represent CQA at study management team and CSP meetings • Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics • Perform miscellaneous duties as assigned

🎯 Requirements

• BS in life sciences or equivalent experience • 5+ years of overall GCP or QA experience, including 2+ years in service provider oversight • Experience in clinical service provider qualification and oversight in pharmaceutical and/or biotechnology companies • Strong interpersonal, written, and oral communication skills • Exceptional organizational and critical thinking skills • Ability to build partnerships and diplomatically work with other departments • Proficiency in relevant computer systems, including MS Office • Ability to remain stationary standing or sitting for prolonged periods • Ability to move about inside an office and exert up to 10 pounds of force occasionally, or negligible force frequently or constantly • Visual acuity for preparing and analyzing data and figures, viewing a computer screen, and extensive reading • Ability to perform repetitive wrist, hand, and/or finger movements • Ability to communicate with others to exchange information • Clear and conceptual thinking, judgment, troubleshooting, administration, critical thinking, task prioritization, problem-solving, analysis, discretion, stress management, multitasking, and deadline management

🏖️ Benefits

• Remote office environment • Up to 20% travel • Equal-opportunity workplace • Application assistance and accommodations available