Roles & Responsibilities: Process qualification and non-conformance investigations and work independently with limited guidance. Provides team leadership to Supplier Quality through cross-functional collaboration with procurement, qualit...
Roles & Responsibilities: Perform non-conformance (Client) investigations within the Track Wise 8 Management System. Execute implementation of CAPAs associated with Client investigations. Maintains a high level of expertise in current r...
Responsibilities: The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regul...
Job Description: We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their conta...
Responsibilities: Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports. Manage high complex studies and support specific activ...
Responsibilities : Supporting core Quality Systems activities (SOP revisions, inspection readiness, metrics). Developing and improving regional Quality System SOPs. Analyzing quality and risk metrics and escalating gaps as needed. Supp...
Roles and responsibilities: Must-Have Skills & Experience. Strong experience in Large-Scale Equipment CQV. Mandatory IOQ experience with Filter Press or Centrifuge (one required). Hands-on execution of IQ, OQ, PQ for capital projects. ...
Responsibilities: This position IS NOT related to shipping OR shipment packaging. This is a manufacturing type position and involves filling of liquid antibodies into small vials in a laboratory environment and using lab instruments such...
-life, and transit testing. Prepare packaging verification and validation protocols and reports in compliance..., shelf-life, and transit testing. Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820. Experience with process...
Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection, operating equipment, raw material/finished goods movement ...