Quality Assurance Engineering
Resume:
Cindy Trimble
Cindy Trimble
Twin Lakes, WI 53181
**********@*****.***
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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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
Steve Baker
Engineering Supervisor
Spring Grove, IL
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