Senior Quality Control Analyst, Lab Technical Support, Analytical
4 days ago
Job Summary:
The Senior Quality Control Analyst, Lab Technical Support, Analytical will support quality control technical support testing and related activities at Iovance's integrated Cell Therapy Center (iCTC).
Key Responsibilities:
- Support quality control technical support testing and related activities at Iovance's integrated Cell Therapy Center (iCTC).
- Support the onboarding of new or updated assays for the QC analytical team and other activities in a newly built facility for cell therapy products.
- Perform GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
- Support thorough GMP investigations for quality events.
- Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures.
- Support technical problem solving for issues pertaining to GMP Quality Control.
- Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.
- Perform technical review of laboratory data and logbooks.
- Operate at a consistent and high level of efficiency, producing high quality and accurate results.
- Support Health Authority inspections.
Requirements:
- Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience.
- Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control or related role.
- Experience in technical writing (e.g., Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
- Must be able to wear all appropriate Personal Protective Equipment (PPE), including but not limited to: lab coat, half face respirator as applicable, safety glasses/goggles, and nitrile gloves.
- Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.
Equal Opportunity Employer:
Iovance Biotherapeutics, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.
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