Specialist I, Quality Control Compliance

Iovance Biotherapeutics • Philadelphia, PA

1d • Onsite

About The Position

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). The Quality Control Compliance Specialist must have a good understanding of cGMP quality records, QC testing/LIMS and quality metrics.

Requirements

• 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
• Successfully interface with multi-disciplined teams in a global setting
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve

Nice To Haves

• experience with cell and/or gene therapy products is a plus

Responsibilities

• 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.
• Creates QC testing Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support the release of final products, both internally and externally.
• Assist with tracking the status of quality records within QC to ensure on-time completion.
• Escalates roadblocks to completion of records and provides potential solutions.
• Perform miscellaneous duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level