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Quality Control Training Specialist

2 months ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time
Job Title: Quality Control Training Specialist, Microbiology

Iovance Biotherapeutics, Inc. is a leading biotechnology company focused on the development and commercialization of novel cancer immunotherapies. We are seeking a highly skilled Quality Control Training Specialist, Microbiology to support our quality control training programs at our integrated Cell Therapy Center (iCTC).

Job Summary:

The Quality Control Training Specialist, Microbiology will be responsible for developing and delivering training programs for quality control microbiology and environmental monitoring at Iovance's Cell Therapy Center (iCTC and/or iPBMC manufacturing site (IOVA-A). The successful candidate will work closely with cross-functional teams to ensure that all training programs meet the highest standards of quality and compliance.

Key Responsibilities:
  • Develop and deliver training programs for quality control microbiology and environmental monitoring
  • Act as subject matter expert (SME) and train new laboratory personnel
  • Lead classroom training for Grade B gowning, perform gowning qualifications, and annual gowning qualification
  • Train staff on gram stain, endotoxin, sterility testing and mycoplasma testing
  • Support technical problem-solving for issues pertaining to GMP Quality Control
  • Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls
  • Perform peer review of laboratory data and logbooks
  • Provide input to functional laboratory and cross-functional team meetings
  • Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results
Requirements:
  • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
  • Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control role
  • Strong ability to develop training materials, conduct training sessions, and evaluate the effectiveness of training programs
  • Successfully interface with multi-disciplined teams
  • Extremely detail-oriented with strong technical skill
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
  • High level of ownership and accountability
  • Demonstrate sense of urgency; ability to recognize time sensitivity
  • Previous experience with GDP, GLP, GMP
Preferred Qualifications:
  • Advanced degree (MSc. preferred)
  • Experience with cell therapy products is a plus
Work Environment:

This position will work in both an office and a manufacturing lab setting. When in the lab, you may be exposed to various chemical/biochemical exposures, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors.