Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies Support internal... and external audits and inspections as a member of the audit/inspection team Perform additional duties as assigned by management...
The Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical... methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. The Senior...
: Participates in the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment..., monitoring, and data flow metrics from the clinical sites, CROs and central labs Supports complex clinical trial activities...
. Responsibilities: Execute GDP/ GMP and business processes in the scope of GD America's Hub with minimum supervision Manage outbound... training materials related to the GD America's Hub Develop and maintain applicable Standard Operating Procedures, Forms...
documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving... will be required to administer the processing of documents via the established Document Processing Review process. May require communication through...
The Clinical Trial Specialist (CTS) is responsible for providing logistical support for one or more clinical trial... are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical...
, PA. Responsibilities: Own and manage the raw materials receipt tracker solution to provide real-time visibility of receipt lifecycle... documentation, ensuring accurate execution of GMP processes, records, and data entry. Support and execute the on-site operations...
with strong tactical execution skills to support the DSCL organization within MCS/DPNIM. The ideal candidate brings 5+ years of clinical.... The ideal candidate is comfortable working in the background of complex supply chain activities—processing orders...
Responsibilities: Support master data activities and analysis related to the external contract manufacturing network...
Our client is seeking a highly motivated Entry-Level Quality Control (QC) Analyst to join the Gene Therapy QC Bioassay... group. This is an excellent opportunity for recent graduates or individuals early in their careers to gain hands...