- Ascensia Diabetes Care (Portsmouth, NH)
- …marketing, R&D organizations, customers and other plants. + Design and execute Validation and/or Qualification exercises in accordance with FDA General ... What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and...clients to carry out the work assigned. + Advanced computer skills, Windows Suite, CAD, Label design. + Advanced… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system… more
- Hologic (Newark, DE)
- …and execution of design assurance activities, including risk management, verification, and validation . + Serve as a technical mentor to junior engineers, providing ... lifecycle, with a focus on software risk management. + Support validation , verification, and clinical preparation activities as required during product development… more
- Bio-Techne (San Marcos, CA)
- …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …role will also support clinical/biomarker assay development and validation . For more information on CMC, click here ... and leadership for Takeda clinical and biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality… more
- Bausch + Lomb (Tampa, FL)
- …QC Laboratory instruments at Tampa site to assure compliance with cGMPs/GLPs/GAMP/ FDA , 21 CFR Part 11, Data Integrity, and Regulatory guidelines/requirements. This ... audits/inspections. + Completes assigned tasks to support Change Management, NC/CAPAs, Validation , or similar requirements. + Supports the development or revision of… more
- Actalent (Minneapolis, MN)
- …+ Provide quality engineering support to US Operations to ensure compliance with FDA regulations. + Act as the first line support for quality issues and ... in change control for products and processes. + Review and author validation documents and validate processes. + Initiate Change Requests to update documentation… more
- BioBridge Global (Norcross, GA)
- _QualTex Laboratories is an FDA -registered and CLIA-certified organization that provides state-of-the-art, high volume capacity donor screening and biological ... lab functions and will also lead initiatives in method development, validation , and suitability studies. Additional responsibilities include, but are not limited… more
- ManpowerGroup (Minneapolis, MN)
- …and Responsibilities:** + Provide quality engineering support to US Operations to ensure FDA /ISO compliance and act as first line support for quality issues. + ... in change control for products and processes. + Review and author validation documents and validate processes. + Initiate Change Requests to update documentation… more
- Roche (Branchburg, NJ)
- …problem solving with regards to the automation systems as well as in the validation of process and facility automation. They may also develop code and design system ... industrial manufacturing equipment for filling & packaging operations in an FDA -regulated manufacturing facility. + Responsible for overall control system concept… more