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...
: 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...
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...
Duration: 6+ months Location: Quincy, MA Responsibilities/Requirements: Responsible for facilitating all the scrum... ceremonial meetings like the Daily Scrum, Sprint planning, Sprint Demo/Review & retrospectives. Helps the Product Owner...
. 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...
Summary: Responsible for the finalization of all work orders, first articles, and customer submittal documentation packages... by performing the following duties. Duties and Responsibilities: Verifies incoming products to ensure products are per purchase...
cycle management (Flex PLM) development. Lead the design and architecture of Flex Product life cycle management (Flex PLM...
, 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...
Our client is seeking a Medical Publications Manager within the Medical Affairs team. This role manages the development... and execution of high-quality scientific publications across the product portfolio within established timelines, collaborates...