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.
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