JOB DESCRIPTION:
The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor. Key
Responsibilities:
-Conduct analytical biological testing of clinical and commercial drug product/drug substance samples
-Perform peer reviews and approvals of laboratory data -Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data
-Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management
-Perform Instrument Calibration and Preventative Maintenance
-Update CRS
-Owned documents using the Document Management System (DMS)
-Order/receive supplies and manage inventory -Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
-Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
-Act as a peer subject matter expert in assessing talent by participating in panel interviews for job
-Complete invalid assay and general laboratory investigation records
-Complete corrective and preventative actions (CAPA) as assigned
-Assist in the execution of internal audits
REQUIRED SKILLS AND EXPERIENCE:
-Minimum one year of relevant GMP QC work experience in Pharmaceutical lab
-Bachelor degree in Biology or Chemistry
-Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
-Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories specifically with Flow Cytometry
-Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
-Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)
NICE TO HAVE SKILLS AND EXPERIENCE:
-CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience
-Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
-Ability to complete equipment and software qualification protocols
-Experience developing and setting long-term objectives
-Experience working in Biosafety Level lab (BSL 2, BSL2+) or aseptic facility
-Knowledge of EU/FDA guidance
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