- Aldevron (Miami, FL)
- …for vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation ... more
- Cytiva (Pensacola, FL)
- …including standard operating procedures (SOPs), process flows, and validation reports.Design, test, and implement new manufacturing processes, equipment, ... more
- Abbott (Columbus, OH)
- …and implementation of the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with procedures ... more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …Validation experience is also accepted + Requires basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. ... more
- Actalent (St. Paul, MN)
- …metrics to senior management. Compliance & Quality: + Ensure qualification and validation processes comply with regulatory requirements (eg, FDA , OTC monographs) ... more
- Actalent (St. Paul, MN)
- … metrics to senior management. Compliance & Quality: Ensure qualification and validation processes comply with regulatory requirements (eg, FDA , OTC monographs) ... more
- PCI Pharma Services (Philadelphia, PA)
- …sterilization process. This includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification, ... more
- Unither Pharmaceuticals (Rochester, NY)
- …change and adapt project scope creep and change in timelines. Understanding of FDA requirements for validation . The ability to analyze and interpret data. ... more
- Boehringer Ingelheim (St. Joseph, MO)
- …of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation , and USDA and FDA /EU regulations. + * Excellence in ... more
- Regeneron Pharmaceuticals (Troy, NY)
- …and sterilization processes in Regeneron's Rensselaer facility. You will participate and defend validation data in FDA and other regulatory inspections. In this ... more
- Quality Consulting Group (Juncos, PR)
- …those trends and established corporate direction. + Some direct experience with FDA or equivalent regulatory body. + Advanced validation knowledge (equipment ... more
- Kelly Services (Minneapolis, MN)
- …pilot batches for new formulations. + **Compliance Leadership** : Ensure all validation activities meet or exceed FDA regulations, OTC monograph requirements, ... more
- Charles River Laboratories (Ashland, OH)
- …+ Ensure methods from the method development are fit-for-purpose, and ready for FDA /EMA validation guidelines (where appropriate). + Ensure on-time and quality ... more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory ... more
- Actalent (Carlsbad, CA)
- …with hands-on GMP experience preferred. + Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies. + Ability to ... more
- Actalent (San Diego, CA)
- …additional Quality Assurance duties as necessary. Essential Skills + Quality assurance + Validation + API + FDA + Pharmaceutical Additional Skills & ... more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and post ... more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and post ... more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and post ... more
- Sanofi Group (Cambridge, MA)
- …with industry's best practices in bioanalytical assay development and regulatory expectations ( FDA and EMA) for validation of PK, immunogenicity and biomarker ... more
