Cindy Trimble

Cindy Trimble

**** ***** ***.

Twin Lakes, WI 53181

ace1rv@r.postjobfree.com

262-***-****

Cell phone: 262-***-****

QUALIFICATIONS

I have 24 years of experience in Documentation and Quality

Systems. My background is in Standard Operating Procedures,

Training and BOM;s. Particular expertise in Good Documentation

Practices, Protocol Training and Documentation Center Training. I

am experienced in working with manufacturing plants and all levels

of business associates. Problem solving, interpersonal,

presentation and multi-tasking skills are some of the strong suits.

PROFESSIONAL EXPERIENCE

Frasenius Kabi

Hwy 22

Lake Zurich, IL 60047 April 5, 2013 – 12-10-13 (Temporary

assignment)

Labeling Associate

Responsible for coordinating all activities pertaining to approved

labeling specifications and procurement of FDA approved printed

materials for all products, including private label and government;

supervising the generation and timely implementation of accurate

labeling in compliance with FDA regulations, 21 CFR, Part 201 and

APP labeling policies and procedures; maintaining an effective

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Cindy Trimble

working relationship with Regulatory Affairs, Production Planning,

Inventory Control (PPIC), Purchasing, Medical Information &

Safety, Business, Product Development Project, Quality

Assurance/Quality Control (QA/QC), Legal, Manufacturing,

Marketing and outside vendors to ensure the availability of

accurate and compliant labeling to meet production needs.

Responsible for the creation of draft labeling for new products

through the use of innovator labeling, or input from Medical

Information and Safety, Product Development, Package

Engineering, and Marketing; making changes where appropriate.

Create labeling in Structured Product Labeling (SPL for XML)

format using specialized software for FDA submissions.

Responsible for routine updates/revisions of product labeling

utilizing innovator or leading competitor labeling or FDA deficiency

letters.

Interacts with contract manufacture customers on issues relating to

labeling; builds and maintains professional and effective rapport

with clients resulting in enhanced business relationships.

Provides labeling documentation [draft or final printed labeling

(FPL) in response to deficiency letters within specified time frames

based on corporate priorities; responsible for accurate

interpretation of deficiency letters, providing accurate, approvable

labeling for FDA submissions.

Coordinate proofreading of labeling artwork; performing review of

draft and final labeling for compliance with USP and FDA

requirements. Responsible for maintaining an error-free

environment with respect to all labeling components and

documentation.

Responsible for timely implementation of FDA approval letters and

the determination of timely destruction of obsolete labeling in

accordance with FDA requirements. Provides current approved

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artwork and electronic files to printing vendors upon request from

manufacturing plants.

Monitors FDA websites for changes in innovator labeling and

labeling regulations. Reviews proposed USP labeling revisions to

ensure timely implementation for APP products. Maintains hard

copy labeling files for current / historical components and updates

databases for current components, DCRs, deficiency letters, etc.;

maintains current label sample files. Provides labeling support for

all active applications for annual reporting regulatory requirements.

STERLING ENGINEERING

977 North Oak Lawn Avenue

Elmhurst, IL 60126

Agile Analyst

November 6, 2012 – March 30, 2013 (Temp assignment)

Experience using Agile 9.3.1.1 and creating BOMs and ECO’s in

Agile. Problem solving skills (helping engineers solve Agile

problems with their ECO’s). Experience building software BOM

structures in Agile and to read process flows and understand inputs

and select the appropriate process based on inputs and desired

outcomes. Ability to communicate with a cross functional team to

gather requirements as necessary and extremely time focused.

The need to respond quickly to resolve issues and many issues

brought to this position need same day, and or resolution within a

24 hour timeframe.

Good firefighting skills and capabilities to not be overwhelmed

easily.

Experience going through Agile, and/or Agile to EBS integrations

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Cindy Trimble

Import and export data for software upload into Agile from large

amount of excel data.

HOSPIRA

LAKE FOREST, ILLINOIS 600045

Change Management Specialist

January 16, 2012-March 16, 2012 (Temp assignment)

I worked on NSAI protocols, final reports, and addendums,

reviewing, scanning, filling and updating the protocol log.

Receive Change Management Forms from plants, review package

for completeness. Packages have 15-20 sign-offs to get for a

completed package. Schedule a Web-ex conference call with the

signatories to make sure everyone agrees with all changes being

made. On the Web-ex conference call the changes are discussed

and if anyone has something that needs to be changed or added or

if information is missing. Then the discussion is made as to who’s

job it is to add the missing data. If a new Web-ex meeting needs to

be rescheduled then the Change Management Specialist will then

reschedule. Once everyone has agreed on the package changes

the CMS can complete the following activities.

The CMS will review the package for content and make any

changes that are appropriate. Then any part numbers that are

being changed the CMS will then start to run where-used reports

on them and continue the where-used report to the lowest level.

Once that is complete a Supplemental Report is then needed due

to the system break down, after you receive the supplemental

report you need to continue more where-used on the part numbers

from the supplemental report (the where-used reports can be

hundreds of pages long).

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Cindy Trimble

An excel sheet is then required of all the part numbers to have a

Sales and Enablement Report run. After the Sales and Enablement

Report are done a cross check is needed to compare that all the

numbers from the where-used have been captured.

A Decision Tree is needed to be filled out by CMS to show all steps

followed to provide justification for your decision on the change

package. For instance: Step 1: Impact to User Needs or Design

Validation, Step 2: Impact to Design Inputs or Verification, Step 3:

Impact to Outputs (specs, drawings, code, etc), Step 4: Impact to

hazard analysis or does change create mitigate safety risk, Step 5:

Is modified output essential to safety or proper functioning of the

device.

Once you have answered all of these questions your package is

complete and can move to the next review.

INTERMATIC, INCORPORATED

WINN ROAD

SPRING GROVE, ILLINOIS 60081

Agile Analyst

July 2008-April 2010

Assisted on the project team to implement Agile a PLM (Product

Lifecycle Management) System. Agile is designed to run parallel

with BCPS manufacturing system.

Implementation consisted of creation of BOM’s, ECO’s testing

workflows and field completion requirements and document results

for each step of the Agile process.

Preformed validation on the Agile system to insure complete

accuracy of inputs and outputs.

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Cindy Trimble

Once the XML translator was ready to push data the Agile team

had to compare BCPS production data to BCPS prototype data,

verify document and report results.

Currently working on a project team with Marketing and Production

Control to “Reduce total SKU count from 1,281 to 700 while

delivering $1.8 million of savings in 2008.

Engineering Information Coordinator

June 2005- July 2008

Maintains engineering database as directed by the Manager,

Engineering Services. Used Business Planning Control System

(BEPC) documentation system to create or modify bills of material;

also performed releases received from the Design Groups.

Maintains route sheet tracking system and database for UPC and

I2of5 numbers .

Maintains database in Item Master as directed by engineering

change orders from Design Group. Handles the flow of engineering

change orders for distribution.

Maintains all engineering data for obsolescence. Experience with

engineering drawings.

BAXTER HEALTHCARE CORP.

1620 WAUKEGAN ROAD

MCGAW PARK, IL 60085

Sr. Doc Ctr. Specialist

1992-2004

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Supported implementation of ERES within the Renal organization;

also assisted in training and counseling of employees on e-file

handling and preservation. Maintained Servers and E-files housed

in Servers.

Reviewed Protocols and Design History Files for GDP, ERES and

issued and distributed them. I also assisted in training and

counseling of employees Protocol requirements within the Renal

Division.

Responsible for start-up and operation of Kardex and Archive

Room. Also receiving, electronic entry, archiving, microfilming,

tracking, maintaining and promptly retrieving all Quality and Clinical

records.

Preformed validation on the Kardex system to insure complete

accuracy of inputs and outputs.

Maintained established retention schedules; created and

developed Standard Procedures for the Archive Room; performed

validation of Kardex System; and worked with Project Leader and

team to create Web-based training for the Technical community.

Assisted in development of training classes for the Renal Division

and instructed employees in all facets of Documentation

Requirements and GDP.

Worked with the computer systems Administrator to automate

manual audit systems for SOPs and Protocols. Automated the

yearly Audit system in FileMaker PRO for SOPs and Protocols, with

a cost savings of $120,000. Prepared monthly reports documenting

the status of all related documentation.

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Cindy Trimble

Ability to create, audit, revise and mark-up and implement standard

procedures, forms, charts, manuals as outlined in the division

standard operating procedures.

I also assisted in the integration of Standard Operating Procedures

into PROSE System.

BAXTER HEALTHCARE CORP.

MCGAW PARK, IL 60085

Documentation Technician

1990-1992

Processed and issued Renal documents.

Handled document change control, routing for approvals, word

processing and structure of BOM.

Used PROSE documentation system to create or modify bill

structuring; also performed releases, proofread, corrected EB

bounces, accessed and updated DDS system.

Coordinated with Engineers, plants and support groups to meet

production schedules.

BAXTER HEALTHCARE CORP.

MCGAW PARK, IL 60085

Label Copy Technician

1988-1990

Proofread, overlaid artwork, measured text with numerous gauges

and worked with HIBC Code.

Created and revised Label Copy packages.

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Cindy Trimble

Obtained new numbers for new Art, input Part Masters into system

and electronically

transmitted document to MDC Data Center to be keyed.

Linked General Specifications to Labeling Specifications.

Prepared packages for Label Copy Meetings, for approval.

BAXTER HEALTHCARE CORP.

MCGAW PARK, IL 60085

Documentation Technician/Quality Analyst

1986-1988

Proofread, overlaid artwork, measured text with numerous gauges

and worked with HIBC Code. Released new and revised 8 series

specifications and artwork. Proofread as a Quality Analyst.

Retrieved and edited "part master" and "where used" information

from the EB report. Structured Bill of Material Processing

Specifications, PCS's and Blueprints. Obsoleted and discontinued

documentation. Maintained DDS System. Also, word processed

Specifications, Change Forms and PCS's.

BAXTER HEALTHCARE CORP.

MCGAW PARK, IL 60085

Word Process-Microlog Index

1986-1986

Responsible for insuring extreme accuracy when processing data

so that no numbers were

transposed. Proofread to insure 100% accuracy. Converted all

word processed material to

Data Processing.

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Cindy Trimble

WELLS CASTING COMPANY,

RICHMOND, ILLINOIS

1984-1986

Secretary

Typed (letters, invoices, reports, quotations, etc.), did bookkeeping,

handled payroll and accounts receivable/payable, maintained files

and handled telephones.

HONEY BEAR FARM

POWERS LAKE, WISCONSIN

1984

Typed (letters, invoices, reports, quotations, etc.), did bookkeeping,

handled payroll and accounts receivable/payable, maintained files

and handled telephones.

INTERMATIC, INCORPORATED

SPRING GROVE, ILLINOIS

1972-1982

Trouble Shooter for New Assembly Lines

Responsible for handling production problems - developed

methods to meet assembly requirements while using easiest ways

to assemble units that met rate and quality standards.

EDUCATION

Business Courses, College of Lake County, Grayslake, Illinois

Fred Pryor Seminars

Renal Institute Classes

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Cindy Trimble

COMPUTER SKILLS

Microsoft Word, Microsoft Excel, Metaphase OMF, Powerpoint,

PROSE, FileMaker PRO, Microsoft Office, Lotus Notes, BPCS,

Item Master and ISOtrain, Agile, Microsoft Outlook, Web-ex.

REFERENCES

Connie Oaf

Manager Division Label DV&CNT

Hospira (formally of Baxter International)

Lake Forest, IL

224-***-****

Steve Baker

Engineering Supervisor

Spring Grove, IL

815-***-****

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