Monique McElroy

***** ********** ****** *** *** Hayward, CA 94544 • 408-***-**** •acbl0l@r.postjobfree.com

Profile

I am a highly motivated Sr Level professional with over 15 years of experience of Quality Assurance

Document Control experience who seeks a challenging opportunity where my skills and expertise

can contribute to the success and growth of your corporation.

Areas of Knowledge & Expertise:

●Document Control ●Quality Assurance

●Bill of Materials (BOM) ●Recognizing deviation and non-conformance

●Change Control (ECO/DCO/ECN’s) ●Internal Auditing certification 2010

●Part Number/Item Master/MRP ●QSR, ISO 13485:2003, FDA 21 CFR

●Creating/revising procedures (SOP’s/MPI’s) ●Part 820 and CE Mark requirements

●Revising International Product Instructions ●Technical File update/preparation

●Creating/Revising flowcharts & drawings ●Device History record review & compliance (DHR)

●Training and Leadership ●Review/processing Non-Conformances (NCMR’s).

●Strong analytical skills & attention to detail ●Finished Goods review and product release

●Product Label creation, review, and approval

●Vendor/Staff Relations Communication

●New Product Launch

●cGMP and clean room environments

●Proactive in planning for requirements

●Manual and Electronic Quality Systems

Software/ Databases

Microsoft Office 2010 BaaN Alliance

Safari (latest version) JDE PDM

Adobe Photoshop Elements 10 Oracle MRP

Windows 7

QAD

Adobe Illustrator CS3

Documentum

Outlook 2010

Master Control

Visio 2003

LiveLink

Adobe Acrobat 9

EXPERIENCE & ACCOMPLISHEMENTS

Quidel Corporation

Title: Quality Analyst

Oct 2009 to Sep 2013

Responsible for maintaining the Document Control system under specific QSR regulations.

Daily DCR/ECO processing, revising procedures, uploading new revisions, archiving obsolete revs.

Responsible for processing new part numbers in Item Master & creating/revising Bill of Materials.

Creating and revising labeling including component labels and box top labels.

Responsible for Batch Record Review & Finished Goods Release.

Responsible for conducting line clearances.

Responsible for processing non-conformances (NCMR) and Deviations.

Part of the Internal Audit Team and also participates in 3rd party audits

Actel Corporation

Monique McElroy Page 2 of 2

Title: QCA Analyst / Document Control Specialist

Jan 2007 to April 2009

Reason for leaving: layoff/company downsizing due to slow economy

Responsible for the QA release of all Finished Goods shipments to customer.

Responsible for Product Label verifications and compliancy

Responsible for review of Batch Records to ensure completeness, accuracy, and compliance.

Responsible for issuing C of C (certificate of compliance) and C of A (certificate of Assurance)

Thermo-Fisher (formerly Microgenics Corp.)

Title: Document Control Specialist II

Feb 2006 to Jan 2007

Reason for leaving: Accepted a position offering much more opportunity for advancement,

visibility, and responsibility

Increased metrics for accuracy & DCR/ECO completion time by creating new checklists & processes.

Responsible for creating labeling and documentation in compliance with the Quality System.

Responsible for entering item master, Bill of Materials, and item attributes into the MRP system.

West Valley Engineering Temp Agency

Site location: Applied BioSystems, Foster City, Ca.

Title: QA Document Control Specialist

Nov. 2003 to Nov. 2004

Reason for leaving: Temporary assignment was successfully completed.

Successfully assisted in converting the paper system into an electronic document control system.

Vialta-Inc, Fremont, Ca. (start-up)

Title: Document Control/ ECO Analyst

May 01 to July 02 (**note: worked for Garrettcom on weekends from 5/01 to 07/01)

Reason for leaving: layoff/company downsizing due to slow profits/ net sales.

Set up a Document Control Center from the ground up.

EDUCATION

2010 SAI Global, San Diego Ca. (Internal Auditing Certification-13485 & 9001 )

1999 to 2001 Academy of Art, San Francisco, Ca (Motion Pictures)

1988 to 1990 Philips (Condie) Business College, Campbell Ca. (Computer Science)

References

Available upon request

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