Iovance Biotherapeutics

Iovance Biotherapeutics

Specialist I, Quality Control Compliance ( Contract to Hire )

Philadelphia

Sponsorship not specifiedDetected 8 days ago
HRGMPCRISPRCommunicationProblem SolvingAdaptability

About the role

  • The Quality Control Compliance Specialist I will be responsible for Quality Control documentation and data management, including issuing testing forms, data filing and storage.
  • This role will also be responsible for Quality Control Lot Lifecycle, including the entering and tracking batches in LIMS and generating Certificates of Analysis (CoA).

Responsibilities

  • Creates QC testing Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support the release of final products, both internally and externally.

Requirements

  • Must be able to remain in a stationary position standing or sitting for prolonged periods of
  • Must be able to work on a tablet or computer for 80% of a typical working
  • Must be able to move and lift 15
  • Ability to handle work-related stress
  • Ability to handle multiple priorities simultaneously
  • Ability to meet deadlines
  • The Quality Control Compliance Specialist must have a good understanding of cGMP quality records, QC testing/LIMS and quality metrics.
  • ability to recognize time sensitivity

Nice to have

  • Performing Quality Control documentation and data management, including issuing testing forms, data filing and data storage.
  • Assist with Quality Control Documentation Project by locating, organizing and compiling documentation files, creating binders, and executing a high volume of standardized, repetitive tasks daily.
  • Maintaining lot lifecycle in LIMS by logging in batches, entering data, reviewing data and reviewing batches.
  • Assist with tracking the status of quality records within QC to ensure on-time
  • Escalates roadblocks to completion of records and provides potential
  • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
  • Minimum (3) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
  • experience with cell and/or gene therapy products is a plus

Skills

  • Extremely detail-oriented with strong analytical, written, and verbal communication skills

Equal opportunity

  • Please contact Human Resources to request an accommodation.
  • If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

This listing is sourced directly from Iovance Biotherapeutics's careers page and normalized into a canonical job model.