System Engineer
Resume:
Marlborough, MA *****
Home phone 508-***-****
Cell phone 508-***-****
E-mail ********@***.***
Lorance V. Cooper
Objective: To obtain a position utilizing my skills and talents with a chance for advancement within a growing company.
Experience:
July 2006 – August 2014 Sunovion Pharmaceuticals Marlborough, MA
Product Complaint Specialist
Perform duties within the Quality Compliance and Audit department to assure that Sunovion and its suppliers achieve and maintain compliance with GMP requirements, so as to help assure commercial sales and successful NDA reviews.
Implemented paperless product complaint filing system.
Review intake information from customer calls to monitor for technical product complaints;
Log the technical product complaint data into the complaint database;
Categorize the complaint and determine the need for investigation;
Coordinate requests and replies to customers for follow-up information on technical product complaints;
Initiate the quality investigation of the product complaint;
Manage the appropriate response to send to customers;
Intake follow-up information related to the complaint and the investigation into the complaint database;
Generate final complaint reports, including a conclusion which assesses whether or not drug product failure occurred;
Maintain the product complaint files;
Document decisions on inquiries that are not concluded to be product complaints;
Prepare product complaint data for audits and complaint committee assessment;
Alert management of issues requiring follow-up;
Develop work instructions for the evaluation and assessment of technical product complaints;
Identify system improvements to manage technical complaints in a timely and more efficient manner.
Coordinate product return kits, track delivery and receipt of samples.
October 2005 - June 2006 Sepracor Pharmaceuticals Marlborough, MA
Regulatory Documentation Coordinator
Coordinate, track, assemble, quality-check, and publish regulatory submissions (both electronically and as hard copy) in accordance with RA documentation procedures, ensuring the timely completion, distribution, and archiving of the submissions.
Format and edit regulatory submission documents in accordance with RA document specifications.
Assist in the planning and preparation of routing regulatory submissions; when appropriate, compose regulatory forms, correspondence, and text.
Organize and maintain the regulatory submissions reference files and archive files, both electronic and hard copy.
Maintain the regulatory communications files, both electronic and hard copy; update the regulatory communications/submissions logs.
Manage requests for access to the regulatory submissions reference files, regulatory communications files, and Central Medical File, controlling disbursement of regulatory records and accounting for returns to the files.
Create and maintain regulatory file information within the Company's electronic document management system, including importing and indexing of files; support system users as appropriate.
Assist in the development of and implement regulatory documentation standards and procedures related to the publishing of both submissions and clinical study reports (both electronic and hard copy).
Create and maintain regulatory project logs /databases, tracking the submission status of preclinical reports, clinical study documents, investigatory, physician INDs, etc.
Organize and maintain the RA workroom, archive rooms, and inventory of submissions supplies and file supplies.
March 2005 – August 2005 Transmedics, Inc. (contract) Andover, MA
Documentation Control Specialist
Responsible for creating and maintaining a Document Change Order (DCO) system
Responsible for reviewing DCOs/ECO's for completeness, then processing document changes.
Initiate the Change Order packages and the approval process and track documents from creation to release, making sure that each change order is processed quickly and accurately.
Responsible for updating documents using Microsoft Word & Excel, AutoCAD, Pro-E)
Responsible for creating and maintaining all ISO related documents.
Responsible for control of all Item masters & Bills of Materials.
Responsible for Calibration Control using Blue Mountain calibration software.
October 2004 – March 2005 Lifeline Inc. (contract) Framingham, MA
Technical Writer
Responsible for creating and maintaining a Document Change Order (DCO) system
Responsible for controlling the procedures per the DCO process.
June 2003 – October 2004 SAGE Laboratories, Inc Natick, MA
Documentation Control Specialist
Responsible for maintaining the Document Change Order (DCO) system
Responsible for maintaining the Engineering Change Control (ECO) system using ADEPT/Intralink the companies Document Control software.
Responsible for reviewing DCOs/ECO's for completeness, then processing document changes.
Initiate the Change Order packages and the approval process and track documents from creation to release, making sure that each change order is processed
quickly and accurately.
Responsible for updating documents using Microsoft Word & Excel, AutoCAD, Pro-E)
Responsible for creating and maintaining all ISO related documents.
Responsible for control of all Item masters & Bills of Materials using
Visibility (The companies MRP system.)
Education / Training:
Somerville Technical Trade High School
Shop: Drafting (4 years) Co-op senior year
Effective Personal Planning (time management)
Adobe Acrobat
Microsoft Word
Microsoft Excel
AutoCAD
SolidWorks
SolidEdge
Introduction to Pro Engineer
Geometric Dimension & Tolerancing
Great Plains eEnterprise
ADEPT Document Management program
Fourth Shift
Visibility MRP system
MS Visio
PowerPoint
ISIToolbox
AERS Adverse Event Reporting System
Solabs for Quality Investigations
Salary requirements & References available upon request.
Contact this candidate