- 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
- 3D Systems, Inc. (Littleton, CO)
- …development teams in project meetings to understand part requirements, validation needs, and certification expectations, translating them into actionable project ... communication skills across all organizational levels * *Technical Proficiency:*Excellent computer skills and comfort with project management tools and platforms… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise SW development teams on ... and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices. + Collaborate on the update of SDLC and operations… more
- IQVIA (Durham, NC)
- …activities for a molecule (writing specification for ADaM, ADaM/TLF programming & validation for both Safety & efficacy), primarily involving legacy data. + Develop, ... Sciences or specific project teams. **Qualifications:** + Bachelor's degree in computer science, math, statistics, biology, pharmacology, or related. + 8+ years'… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …experience. * 3+ years' directly relevant experience, with prior experience in an FDA /cGMP or regulated environment. * Working knowledge of PPAP and IQ/OQ/PQ ... validation techniques. * Strong written and verbal communication skills....or sitting for prolonged periods of time * Frequent computer use * Frequent phone and other business machine… more
- Hologic (Newark, DE)
- …of our mission to improve lives worldwide. **Knowledge:** + Working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and Medical Device Directive ... and regulatory requirements for medical devices. **Skills:** + Strong computer skills, including proficiency in word processing, spreadsheets, and databases.… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …equipment design meets safety and operational standards based on experience and validation from respective stakeholders. + Leads suppliers and external design teams ... ISO standards and Lean Manufacturing concepts desired. + Experience in an FDA regulated quality environment desired. + Willingness and ability to travel domestically… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …requirements and sound understanding of the pertinent Quality System/Regulations. + Computer skills in word processing, spreadsheets and a statistical package ... + Moderate knowledge and understanding of the Food and Drug Administration ( FDA ) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000… more
- Nestle (Franklin Park, IL)
- …packaging material changes (New implementation). + Write protocols and assist with validation activities across the business unit. + Assist in internal audits and ... support external certifications ( FDA , Kosher, FSSC, Organic). + Develop and deliver Quality...dietary supplements industry + Knowledge of continuous improvement + Computer skills to include proficiency with Microsoft Office Suites… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... health authorities, in the scope of the Qualification and Validation area - Lead functional teams or projects by...audits - Fluency in written and verbal English - Computer literate with good working knowledge of the MS… more