Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with int...
Responsibilities: Perform bioanalytical sample analysis using HPLC-MS for regulated studies. Conduct bioanalytical extractions (PPT, LLE, SPE) and optimize sample preparation techniques. Maintain and troubleshoot HPLC-MS instrumentation...
Responsibilities: Develop, optimize, and validate analytical methods for protein-based biologics. Conduct separation techniques, including HPLC (SEC, IEX, HIC) and capillary electrophoresis. Perform routine laboratory tasks such as samp...
Responsibilities: Perform a variety of complex solution preparations in a GxP environment. Responsible for laboratory balance weight checks, pH meter standardizations. Laboratory maintenance (e.g. ordering & receiving supplies; waste di...
Responsibilities: Independently conduct experiments that further project goals. This includes RNA sequencing from initial QC to data generation and completing samples through the Olink workflow. Interpret results to evaluate data quality...
Responsibilities: Provide training and collaborate with the transitioning employee to ensure knowledge transfer. Support the implementation of the Process Operations Management System (POMS) and Electronic Batch Records (EBR). Focus on ...
Responsibilities: Independently perform routine drug metabolism assays and generate high quality data, noting significant deviations to be elevated to senior staff. Collaborate with department team members including Bioanalytical counter...
Responsibilities: Serve as global process support for Deviation, CAPA, Change Control, Reg Client, and Training processes. Facilitate analysis of Quality Systems metrics and performance periodically. Manage Quality Systems deviations an...
Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory ...
Roles & Responsibilities: Bachelor's degree or equivalent plus 4 + years of related work experience or equivalent combination Engages cross functionally to investigate and document compliance events, ensuring timely resolution to ena...
Job description: The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clin...
Responsibilities: The Regulatory Affairs Manager is responsible for providing regulatory compliance services to Merieux NutriSciences' customers in the food, supplement, pet food, and beverage industries, as well as other applicable regul...
Responsibilities: Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight. Manage assigne...
Responsibilities: Operating and maintaining instruments for hematology, clinical chemistry, coagulation, and urinalysis. Interpreting and troubleshooting quality control results to ensure accurate and precise test results. Performing pr...
Responsibilities: As the Regulatory Labeling Specialist, you will be responsible for ensuring compliance with all labeling regulations related to medical devices industry standards set by FDA guidelines. Reviewing product labels against ...
Responsibilities: Perform high throughput quantitative in vivo and in vitro LC-MS/MS analysis, troubleshooting and problem solving of small molecule compounds from various bio-matrices. Operate, perform routine maintenance, and hands-on ...
Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Ma...
Responsibilities: Operating and maintaining instruments for hematology, clinical chemistry, coagulation, and urinalysis. Interpreting and troubleshooting quality control results to ensure accurate and precise test results. Performing pr...
Responsibilities: Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data. Establishes program to evaluate precision and accuracy of production equ...
Responsibilities: Operating and maintaining instruments for hematology, clinical chemistry, coagulation, and urinalysis. Interpreting and troubleshooting quality control results to ensure accurate and precise test results. Performing pr...