Quality Assurance, Change analyst - Document Control

Elizabeth Lipp-Rawski

*****.****@*****.***

cell: 909-***-****

Summary of Qualifications:

Bilingual: English/Spanish

Document Control, Change Analyst

Knowledge of ISO 13485 Medical Devices (QMS), CFR Part 820 (QSR) and ISO9001 Quality Management Systems Requirements, GDP, GMP, CAPA Internal/External Audits

Complaints

Agile Document Management System

Awards & Recognitions:

AMO Development Project of the Year 2013

Work Experience:

Fresenius Medical Care

QA, Change Analyst - Document Control

Lake Forest, CA

April 2015 - March 2017

Supported R&D and operations engineering, quality engineering, human factors engineering, SW/FW engineering group by revising controlled documents and preparing Engineering Change Orders (ECOs).

Managed the approval process to ensure timely release of documentation

Managed multiple documentation assignments in various stages of production to ensure critical deadlines are met.

Worked with Agile Document Management System

Supported internal audits

Supported the CAPA program

Supported the training program in ComplianceWire

Identified problems and opportunities for process improvements. Johnson & Johnson (Biosense Webster)

Johnson & Johnson (Biosense Webster)

Documentation Specialist

Irwindale, CA

Nov 2014 - March 2015

Worked primarily with R&D Engineering team, reviewing and processing the

ECOs (Engineering Change Orders).

Abbott Medical Optics AMO

QA, Change Analyst - Document Control

Santa Ana, CA

April 2010 May 2014

Evaluated and took appropriate actions based on internal and external standards for all AMO product and procedure releases and modifications.

Analyzed and interpreted data using independent judgment to approve, reject, release, or rework change documentation submissions on a case by case basis

Independently assessed and judged proposed product and procedure changes for compliance to regulatory and business standards.

Conducted final verification prior to release or change implementation in Document Management System(Agile).

Monitored, directed actions and/or escalated issues regarding the change processing status to meet project plan release deadlines.

Guided change initiators/originators in the development of accurate changes

Experienced with Agile multi site implementation.

Worked with cross-functional product development teams and diverse departments.

Worked with all levels of employees, including senior management. Avail Medical Products /

Flextronics Medical Company

QA, Change Analyst - Document Control

Santa Ana, CA

October 2001 - March 2010

Assisting the Internal Audit Program.

Coordinated and facilitated Management Review Meetings.

Communicated, by word and example, the importance of complying with ISO 13485:2003

Under minimal supervision, created, reviewed, and processed engineering change orders (ECO’s, CRs, MCO’s Deviations) per company and ISO/QSR standards. Managed drawings, documents, procedures, forms, and device master records for product lines using Agile’s electronic document control system.

Provided training on the Agile system, processes/procedures to support day to day

management and development projects.

Education:

Continuing education coursework; Team Unity skills, Project Management and Leadership Skills.

Seminars: CAPA Warning Letters, Basic of Risk Management, CAPA101

Workshops in Quality Training Systems, Building Your Team, Management Projects, Team Unity and Complaint Process.

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