- J&J Family of Companies (Santa Clara, CA)
- …teams to identify opportunities for improvement + Assure data integrity and data validation prior to publishing reports and analysis + Process confidential data and ... + Support company goals and objectives, policies, and procedures, QSR, and FDA regulations + Other duties as assigned **An internal pre-identified candidate for… more
- United Therapeutics (Research Triangle Park, NC)
- …procurement and utilization + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Abbott (St. Paul, MN)
- …Work with design engineering in the completion of product verification and validation + Work with microbiology to ensure appropriate environmental monitoring and ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Curia (Springfield, MO)
- …objectives, timelines and deadlines + Assist with the maintenance, calibration, and validation of QC lab analytical instrumentation + Conduct investigations of OOS, ... team resources + Expert in cGMP, USP, EP and FDA regulations + Technical competence including the understanding of...interpretation of all lab techniques + Proficient use of computer software, including Microsoft Office Suite (excel, word) and… more
- GRAIL (Olympia, WA)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
- Amgen (New Albany, OH)
- …in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area. **Responsibilities:** + Take ... support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation , and mechanical equipment issues. + Assist during regulatory… more
- Sutter Health (Mountain View, CA)
- …policies and department standards. + Completes all annual competency validation requirements. + Participates in quality improvement processes, including updating ... Drug Enforcement Administration (DEA), and the Food and Drug Administration ( FDA ) by monitoring nursing unit inspections; maintaining records for controlled… more
- Integra LifeSciences (Braintree, MA)
- …archived materials and solutions. + Assist as needed in test method validation , implementation, and execution. + Provide database support, generate reports and ... non-conformance (NC) investigations. + Assist in preparing for and participating in FDA audits, customer audits, etc. + Demonstrate excellent organizational and time… more
- Colgate-Palmolive (Piscataway, NJ)
- …**Responsibilities:** **Product Development & Formulation** + Lead the development and validation of oral care products such as Toothpaste, Mouthrinses and novel ... high-quality commercialization. + Maintain all required documentation under **GMP/GLP** per FDA /ICH guidelines as required. + Documentation may include R&D project… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and creation of reports, etc + Assist with equipment validation activities associated with CGMP process + Assist with...of CGMP regulations + Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards and the ability to… more