Quality Assurance Engineering Specialist

3 hours ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Title: Quality Assurance Engineering Specialist

We are seeking a highly skilled Quality Assurance Engineering Specialist to join our team at Iovance Biotherapeutics Inc. This role will be responsible for providing Quality Engineering oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility.

Key Responsibilities:
  • Support the design, installation, and evaluation of GMP equipment, system utilities, components, products, and computer systems to ensure they are fully operational, effective, and free from defects during the entire system lifecycle.
  • Develop and maintain company documentation, such as quality manuals, Standard Operating Procedures, and Work Instructions.
  • Represent Quality on cross-functional teams to complete projects, address quality issues, and implement quality system improvements.
  • Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity.
Requirements:
  • BA/BS degree in a scientific or engineering discipline.
  • 3+ years of bio-pharmaceutical industry experience in a technical or supporting technical role.
  • 2+ years leading or supporting GxP System implementation and validation.
  • Strong experience developing and executing protocols for single-use process systems, lab systems, and software applications in a cGMP environment.
  • Ability to effectively communicate with management and project team members.
  • Ability to meet deadlines and multi-task efficiently.
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 a Lab setting with various chemical/biochemical exposures, including latex and bleach.

Iovance Biotherapeutics Inc 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.

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