Quality Assurance Operations Specialist I [Contract to Hire]

Iovance Biotherapeutics - Philadelphia, PA

Full-time - Entry Level

Philadelphia, PA

Chemical Manufacturing

About the position

The Specialist I - IOVA-A QA Ops at Iovance Biotherapeutics plays a crucial role in ensuring quality oversight for the manufacture and disposition of irradiated peripheral blood mononuclear cells (iPBMCs). This position is integral to maintaining compliance with cGMPs, CFRs, and ICH guidelines while supporting day-to-day Quality Assurance Operations activities. The Specialist I will work closely with manufacturing and quality control teams to uphold the highest standards of quality in a fast-paced environment.

Responsibilities

• Perform QA Operations 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 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.
• Maintain a collaborative relationship with CMOs.
• Release raw materials and inventory, and prepare release documentation for approvals.
• Support internal audits and regulatory compliance activities.
• Review laboratory investigations and deviation investigations in a timely manner.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.

Requirements

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college.
• At least 2 years of proficient GMP QA/QC experience.
• Experience with electronic QMS (i.e. 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 relevant skills.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities