Manager Engineering
Resume:
Theresa M Lowe
Suffolk, VA 23435
OBJECTIVE: Seeking a challenging position where I am able to utilize my
diverse administrative skills.
EXPERIENCE:
****-*010 Lonza Biologics Inc. (Contract)Lab Support, Burlington, Ma
QA Documentation
. Process documentation with the QA Documentation Dept.
. Reconciled all documentation into Quality books for other departments
to utilize.
. Filed all QA Documentation that was received in the department
according to each group with the company.
. Copied Batch records for Client.
. Archived documentation and stored in appropriate area's with the QA
Department.
. Followed all Process / Procedures according the ISO 9001, ISO 13485,
GMP Requirements & FDA Requirements.
2007 - 2007 HCM - Hyaluron, Inc Contract Manufacturing - Burlington, Ma
Materials Management Dept - Pharmaceutical
Tech 1 - Material
. Create Material Specifications for all incoming Raw Materials and
Component Materials as required by the customer.
. Sign for all incoming material within the shipping / receiving
department.
. Update, maintained and processes all material specifications within QA
/
Document Control Environment.
. Inspect and Label incoming material received within the department.
. Maintain work status log for all Material Specifications within the
Materials Department.
. File all Material Specification according to Client.
2006 - 2007 Kelly Engineering Services (Contract @ Affymetrix, Inc)
Documentation Control Specialist
. Process all ECO's (Engineering Change Orders). DOP, SOP's, BOM's,
(Build
of Materials) Specifications for the Bedford Site.
. Define parts, build boms, implement ECO's and transfer parts in the JDE
System.
. Update ECO's Log on daily basis.
. File and distribute all Documentation, Procedures, etc for the Bedford
Site.
. Schedule ECO / CCB Meeting every week for ECO review and approvals.
. Update weekly status of all ECO's processed within that week.
. Follow all Process / Procedures according the ISO 9001, ISO 13485,
GMP Requirements & FDA Requirements
. Support all Employees in the Bedford Site on any issues, questions,
concerns within Documentation Control Processes and Procedures.
2005 - 2006 Techlink Systems Inc (Contract @ Abbott Bioresearch Center)
Production Support/ GMP Warehouse Group - Administrator
. Process DCO's and MMDM forms for Production changes and
. Vendor/Manufacturinginformation changes within the Production Support
Group.
. Process all MMDM forms for new material part numbers and changes to be
inputed into SAP Processing system.
. Update Purchasing Info Record within the SAP System.
. Administrator Support for GMP Warehouse
. Trained on all Standard Operation Procedures (SOP) within the Product
Support
2004 - 2005 John Leonard (Contract @ Campus Fundraiser) Data Entry
. Input Credit Card Applications for Students within all colleges in the
United States.
. Verified all Credit card applications for Students.
2003 - 2004 Westaff Inc. Imperial Distributors Inc. Auburn MA
(contract assignment)
Data Entry
. Entered Inventory Ticket numbers into Microsoft Excel from productivity
sheet within a
. Manufacturing /Distribution environment
Rohm and Haas Electronic Materials Corp., Marlboro Ma (contract
assignment)
QM Specialist
. Updated Material Part Numbers within the SAP System.
. Processed QM ECN's in SAP.
. Created COA Profile and Inspection Plans for Material part numbers.
. Clean-up of Material Part Number in SAP
2002 -2003 The Davis Co, Marlboro MA (contract @ Waters Corporation)
Purchasing Administrator
. Input, print and distribute Purchase Orders to Buyers & Planners.
. File of Purchase Orders.
. Distribute mail to buyers and managers within the Purchasing
Department.
. Contacting Vendors regarding purchase orders
. Software Documentation for New Products Group.
. Implemented Product Change Requests for all Products.
. Create Purchase Specifications for New Products and attach images.
. Pull part numbers, build boms, and create ECR's in the SAP Processing
System.
. Filing of ECR's.
. Getting signatures for ECR's for Software Documentation Group.
1997-2001 Quantum Corporation
Engineering Services, DLTtape Group - EC Analyst
. Implemented Product Change Requests for all Products.
. Implement Engineering Change Notices and Customer Bulletins.
. Post Engineering Change Notices (ECN) and Customer Bulletins (CB) to
the
Quantum Soft Library (QSL).
. Define parts, build boms, create EC's, implement and transfer parts in
the Oracle Database System.
. Support Solid State Disk Organization for all Engineering Change
Requests.
. Scanned in engineering documentation for Product Change Requests and
Engineering Change Orders.
. Maintain and update Engineering Change Notices (ECN) Status Report and
Solid State Disk(SSD) Engineering Change Status Reports.
. Post Engineering Change Notice Status Report to the Quantum Soft
Library.
. Check Status on all associated Product Change Requests, Engineering
Change Orders, Engineering Change Notices and Customer Bulletins and
documentation in Infocenter Database system.
. Work with Design Engineer's and Managers on changes to Product Changes
Requests.
. Focal person for ISO 9001 Audit on process and procedures.
. Wrote ISO 9001 process for Firmware Release Process.
. Certificate of Recognition for the Successful Completion of the Everest
Pre-DVT Build.
EDUCATION: Graduated from Hudson High School
Assabet Valley Regional Vocational High School - Evening Classes
Framingham State College - Evening Classes
SKILLS:
Word Processing
Work Group Applications (Infocenter)
Into to Data Processing
Interlink Applications
Microsoft Excel 2000
Outlook 2000 E-mail System
Microsoft Word 2000
Oracle Warp applications (NIRT)
Microsoft Access 2000
SSPG Oracle Applications class
Microsoft Power Point 2000
Introduction to computer Fundamentals
Geometric, Dimensioning & Tolerancing
SAP R/3 & R/4 Processing System
Lotus Notes and SOP Procedures
References:
Don Pierce, Manager, SSD Group, Quantum Corporation
Home Phone#: 978-***-****
Judy Muse, Recruiter, Westaff Inc.
Work Phone# 508-***-****\
Email address: mailto:*****@*******.***
Paul Washburn, Quality Manager
Home Phone# 508-***-****
Email address: mailto:********@******.***
Kevin Keefe, Design Engineer
Home Phone# 508-***-****
Email address: ******@*******.***
Michelle Paul, Recruiter, The Davis Company
Work Phone# 508-***-****
Paul Blaquiere, Supervisor II, GMP Warehouse, Abbott BioResearch Center
Work Phone# 508-***-****
Email Address: mailto:****.*********@******.***
Jen Desjardins . Kelly Engineering Services, Burlington, MA
Email Address: mailto:*******@*************.***
Kathleen Daggett: Associate Director of Planning and Logistics, Alexion
Pharmaceutical
Home Phone# 508-***-****
Email Address: *********@*****.***
Kristen O'Brien: Account Manager Lab Support, Burlington, MA
E-mail Address: *******.******@************.***
Work Phone #: 781-***-**** or 800-***-**** Corporate Office
Contact this candidate