Quality Assurance Project

EDWARD VON EMSTER

San Rafael, CA

415-***-**** **********@*****.*** Linkedin.com/in/EdvonEmster

OBJECTIVE

Seeking a position in regulatory compliance with growing responsibilities

in which I can apply my experience, skills and talents

PROFESSIONAL EXPERIENCE

Document Management Specialist (Compliance Specialist II)

(2006 - 2013)

AMERICAN RED CROSS BLOOD SERVICES - Oakland, CA

Responsible as Subject Matter Expert (SME) in document development and

maintaining regulatory compliance documents

Participate in the review, editing and proofreading of document

development

Coordinate with various departments and responsible project leaders in

updating regulatory documents and route for both medical and department

director approvals

Finalize change controls, document packages, and document change requests

from inception to implementation

Responsible for writing, testing and implementing various Validation

requirements for Red Cross Standard Operation Procedures (SOPs)

Distribute regulatory documents to various affected departments that are

impacted by new or revised SOPs, per Code of Federal Regulations (CFR)

Highlights:

Redesigned and Validated Master Table of Contents for easier

management and staff query of 4,300 documents

Assisted in the development of System 3, and 7 Documents in proofreading,

rearranging grammar and ensuring clear communication via Active and Passive

voice, as well as cohesive "how-to" steps

Created a central intranet portal to assist in receiving and implementing

regulatory files to reduce time and risk of error

Created intranet web portal for Departments to use in assistance with their

internal document reconciliations to ensure against obsolete documents

being used. (Currently in review by Headquarters for national

implementation)

Took on role as project leader after detecting and identifying obsolete

procedure

Currently developing intranet-based training resource for use in our

division

Member of Employee Engagement Committee and Employee Wellness Committee

Document Control Specialist

(2002 - 2006)

AMERICAN RED CROSS BLOOD SERVICES - Oakland, CA

Responsible for regulatory compliance for retrieval of unsuitable

products following current Good Manufacturing Practices (cGMP)

Update, maintain and close Biologic Product Deviation files for the FDA

Identify and enter any system problems and establish corrective and

preventative actions

Responsible for writing, testing and implementing various Validation

requirements for ARC Standard Operation Procedures (SOPs)

Collaborate with the Quality Assurance department with FDA correspondence

and audits

Ensure notification timelines are met. This requires:

Notifying hospitals, fractionators and research facilities within 48

hours, and following up after 30 days if no reply

Notifying FDA with initial Biologic Product Deviation Report for non-

conforming blood products

Follow up reporting for the FDA within 30 days and the Center for Biologic

Evaluation and Research within 45 days

Manage the arrival, closure and reporting of customer complaints and

concerns for quarterly reports

Highlights:

Award: Spirit of Excellence, July 2004

LOGIC software Best Practices recognition from Baxter Bioscience, 2005

EDUCATION

(2001) Web Production Certificate

CENTER FOR ELECTRONIC ARTS - San Francisco, CA

(1995 - 1996) Coursework in Graphic Design

ACADEMY OF ART UNIVERSITY - San Francisco, CA

(1994) AA Degree in Communications

COLLEGE OF SAN MATEO - San Mateo, CA

SKILLS

PC & Mac, Microsoft Word, Excel, PowerPoint, HTML, Outlook, IE and

Firefox browsers, Photoshop, Illustrator, Flash, Dreamweaver,

Deviation Tracking System (DTS), LOGIC, NBCS

Page PAGE 1 of NUMPAGES 1 Ed von Emster - Requisition Number

BIO4059

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