Quality Assurance Operations Specialist II [Contract to Hire]

Iovance Biotherapeutics - Philadelphia, PA

Full-time - Mid Level

Remote - Philadelphia, PA

Chemical Manufacturing

About the position

The Quality Assurance Operations Specialist II at Iovance Biotherapeutics is a pivotal role responsible for ensuring quality oversight in the manufacturing and disposition of irradiated peripheral blood mononuclear cells (iPBMCs). This position involves day-to-day Quality Assurance Operations activities in compliance with cGMPs, CFRs, ICH guidelines, and company policies. The Specialist will work closely with manufacturing and quality control teams to maintain high standards of quality and compliance, supporting various QA initiatives and documentation processes.

Responsibilities

• Perform QA Operation activities including review of manufacturing batch records and labeling/packaging operations.
• Support quality assurance processes, controls, and batch history files for QA Operations and Lot Disposition.
• Provide real-time, on-the-floor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives.
• Track and communicate standard work completion and hurdles.
• Interact with Contract Manufacturing Organizations (CMO) and internal teams to ensure efficient and timely batch release.
• Release raw materials and inventory, preparing and organizing release documentation for approvals.
• Support internal audits and regulatory inspections.
• Act as a subject matter expert (SME) and train incoming staff.
• Review laboratory investigations, deviation investigations, method validations, change controls, and CAPAs.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.

Requirements

• Bachelor's degree in Biological/Physical/Chemical sciences, engineering, or equivalent from an accredited university or college.
• At least 4 years of GMP QA/QC experience.
• Experience with deviations and laboratory investigations within an electronic QMS (e.g., MasterControl, Veeva).
• Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals.
• Knowledge of GMP, Good Documentation Practices (GDP), and FDA quality systems.

Nice-to-haves

• Experience with cell therapy products and cleanroom manufacturing.
• Knowledge of cell culture testing.

Benefits

• Competitive salary range of $72K - $91.2K per year.
• Opportunity for contract to hire position.