- Epredia (Portsmouth, NH)
- …marketing, R&D organizations, customers and other plants. + Design and execute Validation and/or Qualification exercises in accordance with FDA General ... Onsite: Portsmouth, NH What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and external Teams in… more
- 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 ... Onsite: Portsmouth, NH What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and external Teams in… more
- PACIV (San Juan, PR)
- …Qualification + Detailed understanding and experience with current regulations for Computer System Validation , such as FDA cGMPs for the 21st Century, ... related work experience with strong knowledge and hands-on experience of equipment/ system commissioning, qualification (C&Q), and/or validation (CSV) in… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- …+ Product release and investigations + Change Management and CAPA + FDA inspections / Regulatory Affairs + Validation Skills/Competencies: + Self-motivated ... (batch records, methods, labels, etc ) + Facility/Equipment Qualification and validation (process/cleaning) + Stability data review / stability coordination + CAPA… more
- Medtronic (Minneapolis, MN)
- …rates. You will have primary focus and responsibility for the validation of design verification test methods for complex electro-mechanical medical devices. ... and other duties may be assigned. + Lead with impact: Responsible for the validation of Design Verification Test Methods for a new Product Development project for… more
- Curia (Albuquerque, NM)
- …fostering skill development and knowledge sharing. + Support Validation and Computer Systems Validation activities to ensure compliance with industry ... maintenance, optimization, and strategic enhancement of control and data acquisition systems for manufacturing, packaging, and support equipment at the site. This… more
- Bausch + Lomb (Tampa, FL)
- … installed at the Tampa site. **Key Activities/Responsibilities:** + Act as system administrator for local QC Laboratory software systems . + Continuously ... as applicable. + Create, remove, deactivate, modify user accounts within QC Laboratory software systems . + Performs system user access review and system … more
- Katecho (Des Moines, IA)
- …engineering systems . + Experience working with, or knowledge of, business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, ... Responsible for designing, installing, and performing risk assessments of quality process systems and statistical techniques internal to Katecho as well as at… more
- Mentor Technical Group (NC)
- …for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as ... comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science...+ Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. +… more
- Terumo Medical Corporation (Caguas, PR)
- …Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright ... basis. This position requires excellent people skills and knowledge in quality systems , and manufacturing processes. This position also has the purpose to ensure… more
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