Quality Assurance Engineering Specialist

1 day ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time
Job Summary

Iovance Biotherapeutics, Inc. is seeking a highly skilled Quality Assurance Engineering Specialist to provide 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.
  • Collaborate with cross-functional groups, including Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation, to identify risks, develop mitigation strategies, and resolve issues.
  • Conduct audits and submission activities to ensure regulatory compliance.
  • Create 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.
Requirements
  • BA/BS degree in a scientific or engineering discipline.
  • 3+ years of experience in the bio-pharmaceutical industry in a technical or supporting technical role.
  • 2+ years of experience 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.
  • Strong professional interpersonal and communications skills, both verbal and written.
Work Environment

This position will work in both an office and a manufacturing lab setting. The candidate must be able to work in a lab setting with various chemical/biochemical exposures, including latex and bleach. The candidate must also be able to work in a cleanroom with biohazards, human blood components, and chemicals.

Iovance Biotherapeutics, Inc. is an equal-opportunity employer and is committed to cultivating and offering a diverse and inclusive work environment.

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