Quality Assurance Specialist

4 days ago


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

Job Summary

Iovance Biotherapeutics, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities

  • Support regulatory inspections and audits
  • Assist in identifying and assigning individuals for inspection/audit team roles
  • Participate in preparation activities related to regulatory inspections
  • Ensure effective and timely quality support of commitments to corporate timelines, milestones, and regulatory requirements
  • Support the management of the Iovance Internal Compliance Framework

Requirements

  • BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 2+ year relevant experience
  • Current and working knowledge of United States Code of Federal Regulations, ICH Guidelines, EU, ISO, and/or other local government regulatory requirements
  • Working knowledge of MasterControl or other programs such as TrackWise, Veeva, or other related eQMS programs preferred, but not required
  • Working knowledge of data integrity principles (21 CFR Part 11/ Annex 11)
  • External and/or internal audit experience preferred, but not required
  • Proven ability to manage multiple projects while maintaining quality
  • Proficient oral and written communication skills
  • Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.



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