QC Analyst - Clinical Release and Stability

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

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience
- Minimum one year of relevant GMP work experience in a lab setting
- Minimum 1 year of experience working with mammalian cell culture
- 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 such as qPCR, cell culture, Flow Cytometry, and/or ELISA
- Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
- Proficient with Microsoft Office applications

Nice to Have Skills & 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

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.