LAURA LYNN LAMPMAN

5530 W 190th St. #136

Torrance, CA 90503

llampman@rocektmail.com

Cellular: 310-713-2278

SKILLS AND ABILITIES

  · Establish, maintain and perform quality and document control functions in full compliance with FDA, ISO, MDD and

CMDCAS standards for an established and start up medical device company.

  · Excellent organizational skills with meticulous attention to details

  · Ability to interact effectively at all levels and across diverse cultures

PROFESSIONAL EXPERIENCE

Covidien

Culver City, CA

Manufacturer of Class I & II Medical Devices

QUALITY / DOCUMENT CONTROL SPECIALIST III

Maintain a compliant Quality and Document control system, assist and support manufacturing in quality control including

the following activities:

  · Conduct and document Internal Audits

  · Implements documentation systems, including QA, RA, QC, Engineering and Manufacturing.

  · Assists in creating, revising and maintaining current and archived controlled documents including document change

order processing, specification and process changes, protocols, etc.

  · Maintains and monitors ECO log and provides notification of all approvals.

  · Creates and maintains SOP’s (Standard Operating Procedures), creates master list of documents, work instructions,

Engineering and Technical files in controlled documents database and files hard copies in QA files.

  · Maintains and updates document control and tracking databases.

  · Adds/Updates/Maintains part numbers and BOMs in SAP system

  · Assists in the compilation of regulatory filing documents and maintains computerized files to support all

documentation systems.

  · Issues, distributes, and updates controlled manuals.

  · Assists and provides guidance in the managing of change process tracking and document requests.

  · Maintains filing of all master documents, ensuring the accuracy and completeness

  · Conduct training sessions based on applicable SOPs and WIs per department requirements.

  · Create employee Training Records for released procedures and maintain training files and matrix for all employees.

  · Follow-up on open CAPAs as well as documenting evidence of closure

PerQFlo

Valencia, CA

Manufacturer of Class III Implantable Medical Devices

DOCUMENT CONTROL SPECIALIST

Maintain a cGMP compliant Document Control system:

  · Initiate, establish and maintain the quality and document control system for a start up medical device company.

  · Maintain quality systems part numbering log including revisions and assign numbers to all documents, drawings and

specifications.

  · Initiate, edit and perform reviews of standard operating procedures and other corporate documentation.

  · Release documents; create and maintain files and send distribution notification for all approved documents and

drawings.

  · Create employee Training Records for released procedures and maintain training files for all employees.

  · Assist in audits both internal and by regulatory agencies as required.

  · Assist directors with creating uniform spreadsheets for data entry input.

  · Coordinate meetings via Outlook.

  · Document and maintain meeting minutes.

Advanced Bionics

Sylmar, CA

5/2007 to 11/2008

Manufacturer of Class III Implantable Medical Devices

DOCUMENT CONTROL SPECIALIST

  · Review Engineering Chang orders (ECO) and attached documents for accuracy and completeness and issue ECO

and part numbers.

  · Scan documents for Change Control Board (CCB) and Product Quality Review Board (PQRB) members and send

via e-mail for ECO review and signature approval.

  · Incorporate redlines into finished documentation, proofread initial release and updated documents and drawings,

Page 1 of 2

6/2009 to 1/2010

1/2010 to Present

troubleshoot any released document discrepancies.

  · Release documents and send electronic distribution for on line review and company use.

  · Update and maintain company ECO and document Revision History log (RevCon).

  · Proofread production labels and check for accuracy.

Medical Research Products

Sylmar, CA

1/2006 to 5/2007

Manufacturer of Class III Implantable Medical Devices

DOCUMENT CONTROL CLERK

  · Establish and maintain Document control systems including issues part numbers and maintain revision control for all

documentation.

  · Organize Change Control Board (CCB) activities and meetings and responsible for efficiency of documentation

signature cycle.

  · Initiate, edit, maintain and perform reviews for Document Action Request (DAR) and Engineering Change Orders

(ECO).

  · Maintain released documentation files in electronic and hard copy versions.

  · Burn software CD and create copies of floppy disks.

  · Incorporate redlines into finished documentation, proofread initial release and updated documents and drawings,

troubleshoot any released document discrepancies.

Gantz Investments

Tarzana, CA

2/2005 to 12/2006

PROPERTY MANAGER

  · Excellent management, communication and tenant customer service skills.

  · Prepare and maintain tenant documentation including tenant lease contracts, monthly rent receipts, and building

maintenance requirements.

  · Routinely inspect and maintain cleanliness of grounds/facilities and assure building equipment functionality and

determine necessary repairs and maintenance.

  · Troubleshoot all tenant and facility issues and discrepancies.

EDUCATION

Sylmar High School

Pierce College

Diploma

Sylmar, CA 90342

Computer Science Woodland hills, CA

Computer Skills: Microsoft Office (Word, Excel, PowerPoint), RevCon software, SAP

Page 2 of 2