Quality Control Analyst I, Analytical [Contract to Hire]
About The Position
The Quality Control Analyst I supports quality control testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control testing programs include but are not limited to, in-process, final drug product, and stability testing with a focus on cell therapy products. This role requires hands-on laboratory experience in at least one of the following: cell culture / maintenance and cell count determination (NC-200), cell based potency assays utilizing various immunoassays (ELISA, ELLA, etc.) platforms, and or identification / characterization / potency assays using multicolor flow cytometry platforms. This position supports the ramp-up of QC analytical release assays and other activities in a newly built facility for cell therapy products. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to meet target turn around times.
Requirements
- Minimum of a bachelor’s degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience.
- Minimum two (2) years of GMP experience in the pharmaceutical industry within a Quality Control role.
- Solid understanding and functional knowledge with hands-on experience with at least one of the following: Multicolor Flow Cytometry, Cell-based ELISA, cell culture with cell enumeration (NC-200)
- Experience in technical writing (e.g., test methods, SOPs, protocols, etc.)
- Detail-oriented with strong technical skills
- High level of ownership and accountability
- Demonstrate a sense of urgency; ability to recognize time sensitivity.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
Nice To Haves
- Experience with cell therapy products is a plus and/or relevant technical skills (NC 200, ELISA, and/or Flow).
Responsibilities
- Perform daily 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.
- Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
- Act as a subject matter expert (SME) on one or more assays and train new laboratory personnel
- Support thorough GMP investigations for out-of-specification test results and other quality events.
- Support technical problem-solving for issues pertaining to GMP Quality Control
- Support product stability programs, including execution of stability testing and final reporting of stability data.
- Initiate and support revisions of documentation, such as SOP, protocols and reports.
- Initiate and support quality records such as deviations, laboratory investigations, CAPAs, and change controls
- Perform peer review of laboratory data and logbooks.
- Update trending data sheet, as required.
- Operate at a consistent and high level of efficiency, while producing high-quality and accurate results.
- Support Health Authority inspections.
- Provide input to functional laboratory team meetings.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
