- Biomat USA, Inc. (Reading, PA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. * Attend… more
- Merck (North Wales, PA)
- …the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with ... regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written...or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated expertise in leading regulatory filings… more
- Bayer (Philadelphia, PA)
- …meetings including program evaluation, required attendance and coordination of high quality meeting reports; + Identifies educational gaps and provides subsequent ... collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- Sumitomo Pharma (Harrisburg, PA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop and… more
- University of Pennsylvania (Philadelphia, PA)
- …research nurses, and staff at Penn and partner institutions to ensure high- quality execution of research protocols. Attention to patient safety, data integrity, and ... position requires adherence to University of Pennsylvania, IRB, and FDA guidelines, and may occasionally involve off-site work or...+ Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the… more
- dsm-firmenich (Exton, PA)
- …development. + Manage the preparation of applicable technical sections of regulatory documents ( FDA 510k, IDE, PMA, CE), grants, & patent filings. + Execute the job ... within the applicable DSM, OSHA, EPA, ISO, FDA , CE, & other requirements. **We Bring:** + A...+ Extensive knowledge and experience working with Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE). +… more
- Sanofi Group (Swiftwater, PA)
- …assessing GCP Compliance in clinical related activities and supporting the Quality Management System to minimize risk. Responsible for the preparation, initiation, ... include coordination and management of inspections, the preparation of Transversal Quality Reviews (service provider / process), and support for project /… more
- PCI Pharma Services (Philadelphia, PA)
- …future of PCI. The Sr. Operations Manager is responsible for the safety, quality , and operational excellence for Advanced Drug Delivery value stream. In this role ... and have dotted line relationships with the support departments, Maintenance, Warehouse, Quality , and other Value Stream members. This role is critical in driving… more
- Mohegan Sun (Wilkes Barre, PA)
- …in a food outlet or preparation kitchen that delivers consistently high- quality food products and presentations. Handles requisitions/purchase orders and ensures ... quality products are received, stored and properly utilized in...their recipes, methods of production and presentation standards. Follows FDA and Health Dept. approved standards for the proper… more
- UPMC (Pittsburgh, PA)
- …Hillman Cancer Center is hiring a full-time QA Associate, Cellular Therapy to support quality assurance for our stem cell labs located at the Hillman Cancer Pavilion ... weekends are required! The QA Associate will coordinate the quality management, safety, and regulatory activities for the Cellular...Drug Master Files that will be submitted to the FDA . Assist to create and maintain the Laboratory Disaster… more
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