Responsibilities: Ensures that statistical deliverables (tables, figures, listings) and study datasets (SDTM, ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies. Assesses study datasets an...
Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets Crea...
Job Summary: We are seeking an experienced Supplier Quality Engineer to support supplier quality initiatives and material quality performance for a short-term, on-site contract role in Perrysburg, OH. The role involves working closely with...
Responsibilities: Projects managed will be small to medium and have impact to the business plan. Establish and lead a multidisciplinary team, potentially in globally distributed locations, in the sustainment of the client's Front Line C...
Essential Duties & Responsibilities: Invoice & Payment Processing: Receive, log, review, and process invoices from US and Rest of World (ROW) external HFE vendors. Coordinate invoice reviews with HFE Project Leads and obtain authorizatio...
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. ...
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 : 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...
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...
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...