Deanna Pare
Document Control / Regulatory Affairs / RGA
- Role
- Rga Coordinator Document Control Specialist Regulatory Affairs Coordinator at Baxter International Inc.
- Location
- Littleton, CO, US
- LinkedIn followers
- 500 followers
About Deanna Pare
Engineering Change Control & Document Change Control Specialist with extensive knowledge…
Experience
Rga Coordinator Document Control Specialist Regulatory Affairs Coordinator
Jan 2006 — Present
RGA CoordinatorProcess RGA orders submitted by Technical Support Specialists.Document Control SpecialistResponsible for the preparation, finalization & security of controlled documents. Change control execution. Design control record management. Quality records management. Training records management. Conduct defect training. Perform internal audits. Update and submit Product/Drug Master Files to the FDA & Health Canada. Records management and records retention.Regulatory Affairs CoordinatorAssist with coordinating activities with the Internal Audit program. Aid in the preparation and maintenance of regulatory submissions and technical files. Aid with the creation and implementation of company procedures. Update and submit Product/Drug Master Files to the FDA & Health Canada. Assist with international registrations.
Education
Lawton College for Medical Assistance
Certified Medical Assistant
1983 — 1984
Dick Grove School of Music
Certificate
1987 — 1991
Regulatory Affairs Professional Society (RAPS)
Regulatory Affairs Certificate
2010 — 2011
Skills
- Project Management
- International Registrations
- Microsoft Office
- Iso Standards
- Technical Writing
- Internal Audit Compliance
- Iso
- Business Process Improvement
- Sop
- Fda
- Process Improvements
- Continuous Improvement
- Quality System Regulation
- Fda 21cfr820
- Product Development
- Standard Operating Procedure (Sop)
- Design Control
- Regulatory Affairs
- U.s. Food and Drug Administration (Fda)
- Data Analysis
- Iso 9000/9001
- Product Launch
- Device History Files (Dhfs)
- Documentation
- Jd Edwards
- Iso 13485
- Sap Erp
- Microsoft Word Expert
- Process Improvement
- Quality System
- Documentum
- Document Management
- Proof and Edit Technical Documentation
- Fda Regulations (Gmps/Gcps/Qsrs)
- Microsoft Project
- Quality Assurance
- Medical Device Directive
- Change Control
- Design History Files (Dhfs)
- Regulatory Submissions
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