Insight Global
Sr. QC Analyst - Cell Therapy
Insight Global, Malvern, Pennsylvania, United States, 19355
Our large pharmaceutical client in Malvern, PA is seeking a Sr. QC Analyst to join their growing Clinical Release & Stability team to support their Cell Therapy group. The Sr. QC 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 samplesPerform peer reviews and approvals of laboratory dataUse electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory dataSupport of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/managementPerform Instrument Calibration and Preventative MaintenanceUpdate CRS-owned documents using the Document Management System (DMS)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 activitiesComplete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversightAct as a peer subject matter expert in assessing talent by participating in panel interviews for jobComplete invalid assay and general laboratory investigation recordsComplete corrective and preventative actions (CAPA) as assignedQualifications:Bachelor's or Master's Degree in a related field of studyPrior work experience with qPCR, Flow Cytometry and/or ELISAMinimum of 1 year of GMP Laboratory experienceMammalian cell culture experience is preferredPay Range : $79,000-$95,000 (can be flexible based on experience)Schedule:
Monday-Friday, 9:00am-5:00pmHiring Method:
6-12 month long contract with a high likelihood of permanent hirePTO:
5 PTO days annually & 3 paid sick daysBenefits:
Medical, Dental, Vision and 401K plans availableExact compensation may vary based on several factors, including skills, experience, and education.
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.
Monday-Friday, 9:00am-5:00pmHiring Method:
6-12 month long contract with a high likelihood of permanent hirePTO:
5 PTO days annually & 3 paid sick daysBenefits:
Medical, Dental, Vision and 401K plans availableExact compensation may vary based on several factors, including skills, experience, and education.
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.