Specialist I, Quality Control Compliance

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

The Quality Control Compliance Specialist I will be responsible for Quality Control documentation and data management, including issuing testing forms, data filing and storage. This role will also be responsible for Quality Control Lot Lifecycle, including the entering and tracking batches in LIMS and generating Certificates of Analysis (CoA). The Quality Control Compliance Specialist must have a good understanding of cGMP quality records, QC testing/LIMS and quality metrics.

Specific Responsibilities 

• Performing Quality Control documentation and data management, including issuing testing forms, data filing and data storage.
• Assist with Quality Control Documentation Project by locating, organizing and compiling documentation files, creating binders, and executing a high volume of standardized, repetitive tasks daily.
• Maintaining lot lifecycle in LIMS by logging in batches, entering data, reviewing data and reviewing batches.
• Creates QC testing Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support the release of final products, both internally and externally.
• Assist with tracking the status of quality records within QC to ensure on-time
• Escalates roadblocks to completion of records and provides potential
• Perform miscellaneous duties as assigned.

Education and Qualifications

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum (3) years of experience in the biopharmaceutical industry within a cGMP Quality Control role; experience with cell and/or gene therapy products is a plus
• Successfully interface with multi-disciplined teams in a global setting
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve

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
• Must be able to work on a tablet or computer for 80% of a typical working
• Must be able to move and lift 15
• Wear proper personal protective equipment when in the warehouse, laboratory setting, e., safety glasses, lab coats, and closed-toed shoes.

Mental:

• Ability to maintain focus and accuracy during long periods of detailed administrative work.
• 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
• Ability to meet deadlines

Work Environment:

• This position will work onsite in both an office and a manufacturing
• Potential exposure to noise, equipment hazards and strong odors

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 description. 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 regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, 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 [email protected].

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