- ThermoFisher Scientific (Greenville, NC)
- …fills). + Experience with pharmaceutical industry technology, especially from a validation , technical or laboratory role would be useful. **Knowledge, Skills, ... sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. +...periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged… more
- Curia (Albuquerque, NM)
- …the Director also supports other quality functions, including QSYS, QC, and Validation , during external engagements. This role is central to maintaining compliance, ... to questions from groups of managers, clients, customers, and the general public. Computer Skills: The ideal candidate will possess a strong technical foundation and… more
- Abbott (San Diego, CA)
- …implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE: * ... Bachelor's degree in Computer Science or Engineering; Master's or doctoral degree preferred....the area of responsibility, including product design, verification and validation , manufacturing and testing activities * Responsible for exhibiting… more
- Medtronic (CT)
- …determining deliverables with limited oversight. + Defines and performs verification and validation activities ensuring products meet user needs and intended use. + ... coaching less experienced engineers. + Working knowledge of applicable FDA and ISO standards. + Recognized expert in engineering...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Medtronic (MN)
- …domestic, international and 3rd party staff members. + Provide testing and validation support to the manufacturer's organization, as applicable. + Keeping accurate ... understand schematics and engineering drawings. + Familiar with the FDA 21 CFR, CGMP for Medical devices. + Excellent...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Mentor Technical Group (Juncos, PR)
- …for Data Analysis + Good Communication skills Project Management + Knowledge in Computer System and Method Validation (Experience preferable) + Strong knowledge ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Sumitomo Pharma (Morrisville, NC)
- …for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity. + Performing inspection and disposition of ... Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents. + Experience in tissue and cell-based… more
- Battelle Memorial Institute (Columbus, OH)
- …in vivo pathogenicity/efficacy/toxicology studies + Participate in the development, validation , and/or qualification of equipment and biological assays + Ability ... necessary equipment to produce high quality data. Operate routine computer programs and perform basic data manipulation in a...with prior experience with, knowledge of, and/or training in FDA Good Laboratory Practices (GLP) + Preference will be… more
- BJC HealthCare (St. Louis, MO)
- …complex molecular instrumentation for the purposes of patient testing, calibration, and validation of the quality of the assay. Delivers precise, timely, and ... + Participates in performance improvement activities and new assay validations--both FDA approved assays and Laboratory Developed Tests. + Provides training for… more
- Cardinal Health (Phoenix, AZ)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more