- Sartorius (Yauco, PR)
- …Experience in Methods related to Cell Culture + Experience in Equipment and Process Validation + Experience with Supplier Qualification and/or raw material ... Regulations. GMP, ISO, GDP Will support several quality functions such as validation activities, process characterization, cleaning validation , QC method… more
- Teleflex (Wyomissing, PA)
- …CAPA procedures. Process Development and Manufacturing Support: * Basic knowledge of process validation , including IQ, OQ, and PQ requirements. * Exposure to ... design and development, requirements definition, edge-of-failure testing, verification and validation testing, and design transfer. You will bring fresh design… more
- Medtronic (Jacksonville, FL)
- …IQ/OQ/PQ. Being able to collaborate with R&D on the identification of challenge samples. + Process Validation - Lead the planning and execution of process ... research and development as they apply to product or process quality. + CAPA (Corrective and Preventive Action): Proficiency...components meet regulatory and quality standards. + Test Method Validation - Lead the planning and execution of test… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BLA, MAA) and/or inspections. + Broad experience across several including process validation , drug development experience, packaging/labeling and understanding ... based on scientific approach. Deep understanding of analytical methods (development, validation , transfer, and monitoring) and product ( process development, CQA… more
- Integra LifeSciences (Braintree, MA)
- …of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Knowledgeable of and applies statistical ... + Supports developing statistically based sampling plans for Design Verification and Validation , Process Validation , or other studies as deemed necessary. +… more
- Integra LifeSciences (Braintree, MA)
- …implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Maintains knowledge of and applies ... results. + Develop statistically based sampling plans for Design Verification and Validation , Process Validation , or other studies as deemed necessary. +… more
- Quality Consulting Group (Juncos, PR)
- …software system requirements, traceability, and testability. + Performs and/or review process validation (not cleaning processes) and equipment documents: URS, ... and Communication skills + Technical writing knowledge + Knowledge of Process validation and Computer software validation (eg requirements flow down… more
- Danaher Corporation (Muskegon, MI)
- …equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) ... Assist and approve deviation investigations, corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation … more
- Lilly (Pleasant Prairie, WI)
- …plan development. + Provides mentorship and QA oversight for change management, QRM, process validation and equipment validation efforts. + Works with ... capability, for a diverse cross-functional staff in Quality, project teams, and area process teams, including mentoring of new Quality and other project staff. +… more
- Reckitt (Salt Lake City, UT)
- …Chemistry, Biology, or Biochemistry, or at least three years' experience in Process Engineering, Validation , Quality Assurance or Quality Control in an ... EMO Process Engineer City: Salt Lake City **We are...are developed and delivered to plan. This will cover validation /qualification of new and existing processes and equipment with… more