Quality Control Analyst - Insight Global : Job Details

REQUIRED SKILLS AND EXPERIENCE:

-Minimum2 years of relevant GMP work experience in a lab setting

-Minimum 1 year of experience working with mammalian cell culture

-Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, Flow Cytometry, and/or ELISA

-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)

-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

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 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