Jane Cotham

Foxboro, MA *****

508-***-****

acry3x@r.postjobfree.com

October 5, 2015

Hello,

If your firm requires a high-energy Quality Assurance Associate with a no-excuses attitude and is up to any task, then I'm the person you're seeking. My qualifications and experience will enable me to fulfill your expectations.

I am particularly interested in a position with your company because of my background in quality and documentation. An example of my work as a Project administrator/Document Control lead include years of service at Invensys/Schneider-Electric in the Validation and Document Control department, working on the China Nuclear Project. When the project began in 2009, we had to set up a brand new document library. We worked with China and Chinese regulations to process documents to meet the contract time frames and deliverables. This project was a massive undertaking and everyone worked tirelessly as a team to document everything that goes into building 8 Nuclear Power Plants in China. This was exciting and difficult project, and at the same time we needed to establish all new requirements to process everything that was needed to make the project successful.

I am happy to say the project has come to a successful end and I am now looking for new challenges and opportunities.

I am interested in interviewing with you. I can be reached at my cell phone number, 508-***-****, to arrange for an interview at a mutually convenient time.

Sincerely,

Jane Cotham

acry3x@r.postjobfree.com

Jane Cotham

Foxboro, MA 02035

Cell: 508-***-****

LinkedIn: https://www.LinkedIn.com/in/janecotham

acry3x@r.postjobfree.com

Validation Project Administrator/Document Control Lead/Quality Auditor

Seasoned specialist with outstanding evaluations across diversified industries. Strong computer literacy with a proven track record of mastering major computer applications and juggling a multitude of complex work assignments to meet the demands of each day. Interact effectively with executives, co-workers, clients, and management experience in Validation, Quality, Document Control, and Medical Laboratory Technology, with 10 years in a supervisory role. Leadership experience includes Document Control Lead on the Invensys China Nuclear Project and Validation Manager of Rhode Island Blood Center.

PROFESSIONAL EXPERIENCE

Responsible for tracking and managing Document Control, contracts, As-built plans, bill of materials, cGMP documents, and procedures following CFR 21 part 11.

Quality Auditor reviewed controlled validation test documents for correctness and completeness.

Worked as a Consultant for Invensys in Pharmaceuticals as a Quality Auditor, Environmental Class A clean room monitor.

Ran validation projects at RI Blood Center concerning, Medical Software upgrades, web upgrades, laboratory testing and instrumentation.

Invensys/Schneider Electric, Foxboro Mass 2011 to 2015

Project Administrator Engineering Validation Department China Nuclear Project

Earned a reputation as a valuable and cooperative coworker by: being fair, honest, and willing to help others when needed; effectively resolving conflicts at appropriate times; and assisting new managers and other staff to become familiar with policy and operations.

• Managed Controlled Engineering Documents for China Nuclear Project

• Monitored and delivered requests for urgent transmittals to project leads and customers to meet specific timelines mandated in contract.

• Maintained Validation Project Controls Schedule, reported to upper management key tasks details and schedule risks.

• Provided key metrics data and reported weekly on department progress to upper management.

• Recognized for generating superior satisfaction by implementing process to deliver management deliverables accurately and on time.

Invensys, Foxboro Mass 2009 to 2011

Document Control Lead China Nuclear Project

Implemented the Controlled Document library for the China Nuclear Project. Worked with engineering, management and the customer in China to follow Chinese government guidelines and timelines as defined in the Invensys China Nuclear DCS (distributed control systems) contract. Followed GMP's (good manufacturing practices) and 21CFR part 11 regulations while setting up the document library.

• Courteously assisted customers in a knowledgeable and respectful manner.

• Designed and initiated excel spreadsheets to track defined dates to return document replies to the customer and engineering staff.

• Took the initiative to reorganize an existing storage room and create a second room to accommodate increased volume of documentation. Facilitated ready access to controlled document and rapid, efficient retrieval for requests for documentation.

• Worked tirelessly within the confines of the contract to process every document, in the appropriate manner requested by the customers.

Invensys, Foxboro Mass 2007 to 2009

Validation Consultant

As Validation Consultant for Invensys I traveled 95% of the time to different Pharmaceuticals globally performing: QA reviews, process validations of the influenza vaccine, and reviews of IQ (instrument qualifications), OQ (operational qualifications) and PQ’s (performance qualifications) of HVAC systems in a new pharmaceutical plant. Also performed Environmental Monitoring and Bioburden testing in newly built Class A Clean Rooms which required certification as a class A technician.

Rhode Island Blood Center, Providence Rhode Island 2000 to 2006

Validation Manager

• Coordinated and managed upgrades to Blood Center computer systems. Monitored and developed validation test scenarios, using requirements from the medical software documentation

• Developed traceability matrix to determine donor deferral status and establish appropriate course of action.

• Coordinated with other divisions (e.g., nursing, hospital services and main laboratory) to resolve problematic issues. Completed reports and maintained detailed diary system of activity.

Rhode Island Blood Center, Providence Rhode Island 1990 to 2000

Main Laboratory Testing Technician/Laboratory Validation Technician/Quality Control

• Competently produced accurate Blood testing results in timely manner, using automated laboratory equipment. Testing included Serology, Hematology, Blood Typing, Elisa Hepatitis/HIV testing.

• Laboratory Validation testing was written, organized and completed using the requirement documentation from the testing or equipment suppliers, on time and completed within company and FDA guidelines.

• Daily Quality Control was processed on all laboratory equipment (instrumentation, refrigerators, freezers, nitrogen tanks, and calibration of centrifuges, following documented procedures.

EDUCATION/CERTIFICATIONS

Education/Certification

Certificate ISO 9001 Auditor- Caliso Training 2014

Associate Science - Medical Laboratory Technology- Community College of Rhode Island 1990

Licensed by American Society Clinical Pathology (ASCP)-1990

Certified National Certification Agency (NCA) in Medical Laboratory Technology-1990

Experience

MS Office 2003 - 2007 (Word, Excel, PowerPoint, Outlook, SharePoint)

Oracle-UCM (United Controlled Management System, developed specifically for Invensys China Nuclear Project)

Adobe Acrobat

EMC Documentum Eroom

DOORS (IBM systems for writing and tracking of documents)

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