- Sumitomo Pharma (Providence, RI)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... + Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support)… more
- Quality Consulting Group (Juncos, PR)
- …Rico & USA. Responsibilities: + Review and approve product MPs. + Approve process validation protocols and reports for manufacturing processes. + Request Quality ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical , biotech, medical devices, and manufacturing industry, is...with processes involved in manufacturing and distribution, QA, QAL, validation and process development. + Demonstrate ability… more
- Kelly Services (Summit, NJ)
- …(laptop) device The Scientist is tasked with carrying out method development, validation , and interpretation of analytical methods for testing consumer products, as ... Chemistry, or a related field experience in the consumer product, pharmaceutical , or biotechnology industry. + Extensive hands-on experience with analytical… more
- BeOne Medicines (Pennington, NJ)
- …products. Direct analytical team on the studies of the characterization of in- process , release, and stability samples in support of manufacturing operations ensuring ... The position requires strong cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as well as external… more
- Aston Carter (South San Francisco, CA)
- …clearly defined, approved, and delivered. + Accountable for Computer System Validation (CSV) activities in a GMP/GxP-regulated environment. + Manage project teams ... responsible for creating and maintaining validation documentation in alignment with SDLC and regulatory requirements. + Ensure inspection-ready documentation and… more
- Cordis (Irvine, CA)
- …for environmental monitoring, bioburden and endotoxin control, supporting sterilization validation and monitoring, and microbiological risk management. The role ... and trending of bioburden, endotoxin, and microbial contamination for raw materials, in- process , and finished products. + Lead regulatory delegated PMA activities in… more
- Kelly Services (Princeton, NJ)
- …BLA. + Author technical documents including SOPs, test methods, method validation protocols/reports, and material specifications. + Lead investigations for **OOS, ... analysis and compliant documentation. + Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission. + Lead… more
- Sartorius (Hondo, TX)
- …limit, sterility, endotoxin, etc.) based on risk analysis of product, environment, and process . + Review and support method transfer, validation , and related ... subject matter expert in laboratory setup, method transfer and method validation . Provides technical input and documentation support for Qualification activities.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …CMC process development + Experience with analytical method development, validation , and control strategies of biologic products (eg HPLC, CE-SDS. iCIEF, ... is expected to serve as the analytical lead/representative on PDM ( Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for… more
- Actalent (Camarillo, CA)
- …packages that support swift industrialization. Skills Medical device, biotechnology, pharmaceutical , single use technology, injection molded plastic part design, iso ... orders, Engineering Change request, CAPA Top Skills Details Medical device,biotechnology, pharmaceutical ,single use technology,injection molded plastic part design,iso 13485,cad experience,solidworks,autocad,gmp,bill… more