Quality Control Analyst I ( Contract to Hire )
Iovance Biotherapeutics
- Philadelphia, PA
- Contract
- Full-time
- 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.
- 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)
- Experience with cell therapy products is a plus and/or relevant technical skills (NC 200, ELISA, and/or Flow).
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 30 pounds.