Koreen Bailey

**** **** ***** *******

New Brighton, MN. 55112

Telephone: 612-***-****

E mail: ace85n@r.postjobfree.com

SUMMARY

I am a motivated, organized, self starter with 20+ years of experience in the medical manufacturing field.

I am an experienced supervisor that has worked very closely with engineering, upper management and

CEO’s in many different capacities, specializing in document control, quality systems, customer service,

QA and R&D. Recognized by superiors for outstanding service.

EDUCATION

Concordia University, St. Paul, MN

Bachelor of Arts Degree in Organizational Management

Anoka Hennepin Technical College, Anoka, MN

Web Design and Development

TECHNICAL SKILLS

Microsoft Office Enterprise Networking Power Point Auto Cad DBMS Fourth Shift Account Quick Books

Software Development Agile Programming Languages E Commerce Grand Avenue Graphic Design for

Web Sites Multimedia Development AS400 File Maker Pro 6 & 7 Web Script Languages Lotus Notes

6.5.4 SolidWorks 2009 3DVIA Composer MS Office, including the use Microsoft Word, Microsoft Excel, and MS

Outlook.

EMPLOYMENT

Antares Pharma, Plymouth, MN / Oct 2013 July 2014

Position: Document and Change Control Specialist

Responsible for generating document and change control policies and procedures that comply to

FDA, ISO and other relevant requirements, a n d for driving compliance to such policies and

procedures.

Responsible for the maintenance of the central document c o n t r o l library and related content in

compliance to ISO and FDA procedures and standards.

Maintain and manage hard copy and electronic documents including master and history files,

management review, and other quality records.

Responsible for overseeing the Engineering Change Orders (ECO) system and document control

and related processes.

Control ECO workflow cycle across all functions. For example: Engineering, Marketing, Sales,

Production, Purchasing, and Quality to ensure adherence to policy.

Facilitate change control meetings for document change orders, notification of document review prior

to meeting, and work with teams to ensure documentation is released on time.

Receive, review, and format documents in preparation for the review and approval process.

Finalize Document Change Orders for release and notify affected parties of document

revisions.

Maintain complete and accurate documentation and files.

Track and update design history files, technical files, design dossiers and change documentation

as needed.

Maintain database systems; regulatory common technical documents, CAPA, training, and

auditing as required.

Manage the archival of quality records, in addition to licenses and registrations, etc.

Assist QA and R&D with technical documentation.

Coordinate labeling content and control activity, which may include, but not be limited to,

labeling development, language translations, bar coding, etc.

Assist external audits and inspections with the coordination, preparation and compilation of

document packages for inspections.

Optimize and update the ECO process, as needed.

Train appropriate personnel on the ECO process and any related updates.

Define and prepare performance metrics related to document and change control activities and

goals for periodic report on status to management.

Participate In continuous improvement programs, as needed.

Ensure that ECO initiatives meet the prescribed time, quality objectives and error/correction

for ECOs.

Ensure that departments enter information correctly, on time, and address gaps, as appropriate.

Performs duties and tasks as prescribed in company policies, procedures and work instructions.

Boston Scientific, Maple Grove, MN / Oct 2012 Oct 2013

Position: Documentation Analyst Coordinator

Boston Scientific acquired BridgePoint Medical in October of 2012, I became part of the

acquisition/integration team and have been helping in the migration of one company into the other.

This involves: Moving the facility from Plymouth to Maple Grove and running as a subsidiary of Boston

and still ran in the Bridgepoint Medical quality system. I worked with the document services department at

Boston Scientific to get all the documents put into the Boston system. This means, my duties remained

the same as a BridgePoint employee, however moving into Boston things were handled differently as part

of the document controller.

BridgePoint Medical, Plymouth, MN / Mar 2011 Oct 12

Position: Documentation Analyst Coordinator

Provide document control support for SOPs, Records, Material Specifications and Product Specifications.

Responsible for maintaining, updating, and archiving master and support documents.

Generate and process documentation through the Change Order System.

Establish and maintain Device History Records.

Process controlled documentation within quality system requirements.

Provide administrative support to QA.

Respond to internal customer queries on document status.

Management of the filing system.

Enter inspection data into MS Excel and Statistical Management software as required for statistical

analysis.

Enter data into the Manufacturing Resources Planning (MRP) function.

Responsible for adhering to all rules and policies regarding the proper handling of corporation documents.

Educate employees on the policies concerning documentation.

Flexible to adjust to daily changes in duties.

Excellent interpersonal, organization, computer and project management skills.

Excellent oral and writing skills to communicate technical information.

Demonstrated sound judgment in reviewing technical data, protocols, and applying quality principles.

Software applications: Microsoft Office Suite (Visio, Excel, Word, Access, etc.), Solidworks.

Other Duties Monitor and log Calibration and Preventative Maintenance items, Manage new hire training

records, Order and manage standards, Manage Special Work Orders and Deviations, Manage Approved

Supplier list, Manage Scanning of all MFG Travelers, Document Distribution, CO Disposition, All

document Filing.

Take inventory and order office and janitorial supplies; snacks for the office.

Interact with all departments.

CSI, New Brighton, MN / Dec 2009 – Mar 2011

Position: SR. Document Control Specialist

Adhere to and enforce CSI policies and procedures related to document control.

Effectively follow SOPs, policies, and GMPs to provide support for the Quality System during corporate

audits, actively participate in department activities.

Performs activities to coordinate the release of all controlled documents/records of Document Control,

including distribution and auditing controlled documents, creation, maintenance of paper and electronic

document and the electronic directories they are stored in.

Issuance of all part and document numbers

Maintains and posts revision changes to all part and document numbers in the Document Control

database and notifies affected departments.

Maintains Part Master in ERP system setting up new part numbers and updating revision information as

required.

Applicable change control using Engineering Change Orders (ECO’s) along with the tracking and

reporting on document review progress to ensure that documents requiring approval signatures are all

appropriately executed.

Examines documents to verify completeness, accuracy of data, and consistency of document format and

system concerns.

Work with document originators or engineering on technical subjects in a positive, collaborative manner to

prepare controlled documents which conform to CSI’s defined format and resolve discrepancies and

complies required changes with documents.

Communicates and coordinates with all business areas to consistently maintain appropriate records

management and procedures.

Work independently to facilitate group activities.

Coloplast, Vadnais Heights, MN / Feb 2009 – Dec 2009

Position: Validation and documentation associate

Coordinate and execute documentation and Change control activities for new equipment, processes, and

products.

Execute documentation and Change Control activities in relation to transfer of equipment.

Execute documentation transfer between Coloplast sites.

Responsible for approval of request and approval to implement of Change request, within Global

operation, Global Marketing and Global R&D.

Educate and train nonexempt and exempt employees in Global operation and R&D in Change Control,

documentation and resulting document changes.

Change Control and Documentation facilitator for colleagues.

Work closely with all departments related to manufacturing documentation (Manufacturing, RA/QA, R&D,

and Marketing.) to define documentation change needs and to ensure such changes are incorporated in a

timely and compliant manner.

Ensure that all Change Control created by engineering meets established standards and requirements.

Write and modify procedures regarding Validation and Documentation group including text, schematics,

graphic illustrations, and digital images.

Ensure the consistency of document content across multiple configurations of the same product family.

Spectrum Plastics Group, Saint Louis Park, MN / Mar 2007 – Feb 2009

Position: Engineering Technical Coordinator

Maintain master project documentation files, process ECO requests, and maintain project history files.

Maintain general standards SPEC library.

Maintain Standard Operating Procedure System.

Maintain new hire SOP training and term employees database.

Maintain Product Evaluations / Validations /Supplier Standards.

Maintain Customer Approvals.

Assure that documentation conforms to appropriate Regulatory, QSR, MDD and ISO/EN guidelines.

Participate in providing document/data records as required to satisfy internal and external audits.

Provide support in general word processing, presentations, and documentation graphics (flow charts,

simple diagrams, etc.) as requested by department manager.

Informative interfacing and interaction with all department levels of the company.

AGA Medical, Golden Valley, MN / May 2006 Sep 2006

Position: Document Control Specialist

Provide support for the Configuration management (CM) Change Order system (ECO/DCO) by assuring

that documentation conforms to appropriate Regulatory, QSR, MDD and ISO/EN guidelines.

Participate in providing document/ Data records as required to satisfy internal and external audits.

Set up and maintain configuration Items Master list and BOM’s using business system software (fourth

shift/Agile) This includes consulting with “Change order” originators and engineering personal to

determine requirements associated with the BOM’s/Item Master DWG’s and other product data.

Provide necessary support to ensure proper creation, coordination, filing management storage, and

retrieval of all controlled engineering and quality system documents.

Train appropriate AGA personal on aspects of the documentation control system as required.

Synovis Medical, Lino Lakes, MN / Apr 2005 – Dec 2005

Position: Document Control Specialist

Responsible for the generation, storage, inventory, photocopying, filing and archiving of all Quality

System and Engineering Change Orders (ECOs).

Maintain open communication with Engineering QA/Marketing and sales departments to ensure

understanding and maintain balance of their needs, goals and objectives.

Uromedica Inc., Plymouth, MN / Jul 2001 Oct 2004

Position: Quality Systems Technician/Documentation Control

Responsible for all the income receiving inspection activities along with first article / in process and final

inspection, Issuing inspected materials to inventory after parts cleaning activities have been completed.

Proficient in the use of inspection tools, calipers, micrometers, optical comparators.

Working with quality systems supervisor and engineering in handling all the document control (ECO’s).

Monitor product review requests (PRR) deviations and engineering builds. Process validation and design

verification activities. Also Review all the travelers for accuracy and completion.

Worked on the team for internal and external audits.

Handled invoices / purchase orders and basic file management.

Built the company website using HTML.

Medtronic, Fridley, MN / Jun 1986 Sep 2001

Position: Supervisor Manufacturing EP Systems. Catheter Assembly (1998 2001)

Supervised 13 people and three product lines in a clean room / pilot line / R&D atmosphere. Setting up

the manufacturing lines to work within the demand flow technology (DFT) reduced total product cycle time

(TPCT) and fully allocated product cost (FAPC).

On the team for hiring interviews and performed performance reviews. Also ensure orientation and

training of new employees was completed. Along with implementing and maintained training records, and

ensured cross training

Worked as the inventory coordinator and parts handler to ensured adequate tooling, supplies and

materials were readily available to assemblers. Remained current on product assembly process and

material changes and requirements.

QA Inspection of all devises ready for packaging, along with documentation verification.

Final packaging and shipping and receiving coordinator, this involved setting up transportation for devices

going to sterilization and to the main warehouse for distribution.

Worked closely with engineering to write manufacturing processes. Certified in design of experiment

(DOE) and statistical process control (SPC).

Performed inventory and final product transactions (AS400 system). Performed electronic ‘pulls’ from

stores.

Worked on the team for internal and external audits.

Position: MFG Team Member Neurological Leads Assembly (1995 1998)

Position: MFG Team Member Brady Pacing Molding (1986 1995)

TRAINING AND CERTIFICATIONS

ISO 13485 Certification Six Sigma Good MFG Practices Quality System Regulations Blue Print Reading

SPC Statistical Process Control FDA Code of federal Regulations Coaching and Team Building Skills for

Managers Demand flow technology/Just in time Clean Room Certified Lean Manufacturing

Manager Reference:

Craig Schlawin

BridgePont Medical Inc.

Work: 763-***-****

Tracy Keeney

CSI Inc.

Cell: 952-***-****

Professional References:

Mary Jones

Colleague from Medtronic;

Cell: 763-***-****

Chris Haenisch

Colleague from Spectrum Plastics;

Cell phone: 763-***-****

Sherri Kanduth

Colleague from BridgePoint Medical

Cell Phone: 763-***-****

Contact this candidate