4 qc analyst jobs found

Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility.  Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.   Note, this is a shift based role (12/7 - extended days) As a QC Micro Analyst a typical day might include, but is not limited to, the following: Entering a laboratory cleanroom’s to collect and log samples for microbial analysis Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs) Performing sample analysis for microbial identification Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas Performing acceptance testing of commercially prepared microbiological culture media. Autoclaving microbiological media and laboratory waste as needed Ensuring that all work...

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

Within this role you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.  As a Senior QC Scientist a typical day might include, but is not limited to, the following:   Executing investigation testing (FT-IR, SEM, ICP-MS, SEM, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support Evaluating/interpreting data, author and review technical documents for investigational testing Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices Participating in routine maintenance and troubleshooting of laboratory instrumentation Liaising with contract laboratories as required to support investigational analysis Tabulating results and writing summary reports of assay development and validation studies Presenting findings at group...

As a QC Staff Scientist in Biochemistry you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development/validation and/or transfer. In this role a typical day might include, but is not limited to, the following: Participating in assay development/validation for QC Reviewing and approving new test procedures and assays Evaluating new methodologies, techniques and equipment when new procedures are warranted Participating in transfer of methodology from R&D Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed Evaluating assay performance through yearly method performance reports Facilitating assay transfer from R&D and to business partners Providing technical input into additional studies supporting regulatory filing e.g.. Bridging/comparability...