- United Therapeutics (Eden Prairie, MN)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... activities and maintenance/repair visits + Execute and support calibration and validation efforts for production area equipment and processes + Coordinate… more
- Abbott (Pleasanton, CA)
- …in regulated industries (medical devices, pharma, healthcare). + Knowledge of FDA software validation processes. + Experience with real-time monitoring ... Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO 13485). + **Observability** :...into application design. + Work closely with QA and validation teams to support software verification and validation… more
- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more
- Abbott (Temecula, CA)
- …design change projects + Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation ... + Lead design test and inspection method development, and lead method validation activities + Ensure DHF content completion, integrity, and regulatory & standards… more
- Curia (Rensselaer, NY)
- …FLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation , including a minimum of 2 years supervisory experience + ... team resources + Expert in cGMP, USP, EP and FDA regulations Knowledge, skills and abilities + Ability to...interpretation of all lab techniques + Proficient use of computer software, including Microsoft Office Suite (excel, word) and… more
- Lilly (Branchburg, NJ)
- …upgrading software applications for system management, compliance, and data integrity Partners with Computer System Validation (CSV), IT, QC, and QA to ensure ... implementation, and maintenance of computerized systems. Authors and reviews computer system administration procedures and policies. Serves as technical lead… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Establish master data architecture frameworks to enable system deployment, ensuring validation and regulatory compliance across FDA -regulated environments. + ... Comprehensive understanding of biopharmaceutical manufacturing processes, batch record requirements, validation standards, and change control procedures within FDA… more
- AbbVie (Barceloneta, PR)
- …multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw ... with AbbVie policies, ABL plant procedures, Food and Drug Administration ( FDA ), EMA, and other applicable regulatory agencies cGMP regulations and requirements.… more
- Abbott (Scarborough, ME)
- …knowledge of manufacturing equipment and processes. + Leads design of experiments, validation , completion of testing and analysis of data. Presents data to cross ... manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical… 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 ... with other departments to support equipment such as calibration or validation activities, inventorying materials, and coordinating disposals, as needed + Prepare,… more