Julia Warren
Design Control Manager, Ethicon at Kelly Services
- Role
- Project Manager Design Control, Ethicon at Kelly
- Location
- Plainfield, NJ, US
- LinkedIn followers
- 500 followers
About Julia Warren
I have worked as a Project Manager and Business Analyst in the telecommunications and…
Experience
Project Manager Design Control, Ethicon
Dec 2013 — Present · Somerville, NJ, US
Prepare and execute change project(s) to facilitate compliance to the design control procedures within ADAPTIV in support of the technical file remediation. The processes include the initiation and project management of the label changes with business partners (Labeling/Regulatory Affairs/Supply Chain) across Ethicon network of plants.
Skills
- Manufacturing
- Iso 13485
- Glp
- Quality Assurance
- Technology Transfer
- Software Documentation
- Computer System Validation
- Pharmaceutics
- Cleaning Validation
- Continuous Improvement
- Lims
- Regulatory Affairs
- Ssgb
- 21 Cfr Part 11
- Trackwise, Ms Office, Software Test Design and Testing
- Medical Devices
- Capa
- R&D
- Clinical Trials
- Quality System
- Quality Control
- Gmp
- Biotechnology
- Six Sigma
- Quality Auditing
- Management
- Clinical Development
- Change Management
- Change Control
- Regulatory Submissions
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- Trackwise
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