QC Microbiology Data Reviewer & GMP Documentation Specialist role supporting GMP microbiology operations through independent r. eview of microbiology data. . documentation. and. electronic records. to ensure accuracy, completeness, and. ALCOA compliance. The role focuses on review of. EM. bioburden. . sterility. . endotoxin. and. media qualification. data. along with. writing deviations, CAPAs, SOPs. and routine. GMP reports. Ideal for an interme...
QC Microbiology Data Reviewer & GMP Documentation Specialist role supporting GMP microbiology operations through independent r. eview of microbiology data. . documentation. and. electronic records. to ensure accuracy, completeness, and. ALCOA compliance. The role focuses on review of. EM. bioburden. . sterility. . endotoxin. and. media qualification. data. along with. writing deviations, CAPAs, SOPs. and routine. GMP reports. Ideal for an interme...
We are looking for a Associate Engineer to join the raw materials team within the CTTO (Cell Therapy Technical Operations) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation ...
We are looking for a Associate Engineer to join the raw materials team within the CTTO (Cell Therapy Technical Operations) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation ...
We are looking for a Associate Engineer to join the raw materials team within the CTTO (. Cell Therapy Technical Operations. ) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviat...
We are looking for a Associate Engineer to join the raw materials team within the CTTO (. Cell Therapy Technical Operations. ) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviat...
We are looking for a Associate Engineer to join the raw materials team within the CTTO (. Cell Therapy Technical Operations. ) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviat...
SOKOL GxP Services is seeking a. QA Label Control Specialist (2nd Shift). to support our client's. Cell Therapy Manufacturing facility. in Summit, NJ. In this role, you will execute label control, issuance, and printing activities to ensure compliance with. FDA, cGMP, and internal quality standards. for clinical and commercial cell therapy products. You will be responsible for preparing, verifying, and issuing. in-process and final product labels...
Cell Core supports multiple internal organizations by supplying high-quality cellular products that fuel the development of next-generation T-cell therapies. We are seeking a hands-on. Assistant Scientist. who thrives in the lab and enjoys keeping complex workflows organized and moving. If you are comfortable juggling technical tasks, managing inventory with precision, and communicating across a busy cross-functional landscape — you'll fit in per...
The Label Control Specialist at the Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at the facility in accordance with client’s policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in process and drug product label printing activities. ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Devel...
The Supply Chain Planner will manage material planning and purchasing activities to ensure on-time delivery and optimal inventory levels for clinical trial product manufacturing. This role coordinates with manufacturing, QA, QC, and cross-functional teams to align production schedules, resolve material shortages, and maintain supplier relationships. Responsibilities include developing replenishment strategies, managing supply forecasts, and drivi...
Working Schedule. . Mon - Fri, 8:30AM – 5PM. . Effective Date. 14JUL2025. . FLSA Classification. FT/PT | Non-Exempt/Exempt. . Work authorization. . Applicants must have the legal right to work in the United States without requiring sponsorship. . Corp-to-Corp (C2C) arrangements are not accepted. DUTIES AND RESPONSIBILITIES. . Provide. QA support. to the Devens site and QA Manager by reviewing and approving investigations and corrective actions (C...
