Quality Control Compliance Specialist, CAPAs & Change Controls

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC) Compliance Investigator who will in advance and close QC related investigations. Strong technical writing skills are required. Experience in a CAR-T or TIL environment is a plus.

The ideal candidate will have experience working in a GMP-regulated laboratory with experience in writing investigations.

Essential Functions and Responsibilities

• Develop CAPA project plans, outlining key milestones, deliverables and timelines.
• Work cross-functionally with stakeholders to define action items, assign responsibilities, and track CAPA implementation.
• Monitor and report on CAPA progress, ensuring adherence to project timelines and regulatory commitments.
• Conduct post-implementation verification to assess CAPA effectiveness.
• Support QC management in metric analysis and generation.
• Support deviation investigations for all areas within Quality Control, as needed.
• Support maintenance of a database in support of QC metrics and KPI’s.
• Revise quality documents in support of deviation mitigation and/or CAPAs.
• Other responsibilities as determined.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• 1-3 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
• Basic knowledge of biological drug development with respect to Quality Control
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challeng
Preferred Education, Skills, and Knowledge

• Experience with cell and/or gene therapy products
• GMP regulated laboratory experience
• Knowledge of investigation writing

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 Sit for an extended amount of time in front of the computer or biological safety cabinet

Mental:
• 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; and ability to meet deadline

Work Environment:
• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and 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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