Senior Documentation Specialist Resume Example Boston Scientific

SENIOR DOCUMENTATION SPECIALIST

Professional Summary

Senior Documentation Specialist looking to advance my career within the medical device and pharmaceutical industry. Over 5 years experience implementing, training, and managing product life-cycle management systems.

Skills

Document/Record Control
Standard Operating Procedures (SOPs)
Internal/External Audit Support
MS Windows Proficient
Training Coordination
Systematic Problem Solving
LEAN
Project Management

Windchill, PLM, Arena
NCEP/CAPA
Fast Learner
SAP
Good Practice Documentation
Parts, BOMs, and Routers
eCAD/Soildworks
Business Process Lead

Work History

Senior Documentation SpecialistMay 2015 - Current
Boston ScientificCambridge, MA

Prepares new and revised documents for routing per local and corporate document approval process. Tracks progress in obtaining approvals to for document change notices to aid in timely approvals.
Maintenance of three (3) documentation systems while integrating a new company acquisition (Rhythmia to Boston Scientific)
Incorporates documentation edits and updates all logs associated with documentation status. Releases approved documents and notifies affected personnel of changes impacting functional areas.
Suggests changes to processes, documentation, and training programs in the spirit of continuous improvement.
Supports teams in implementation of quality systems upgrades.Monitors and documents compliance with the local training program to ensure training compliance.
Certified site trainer of current documentation management system (Windchill 10).
Supports internal, regulatory, and notified body and audits.
Interacts between functional groups regarding Document Change Notices.
Facilitates Document Review meetings and makes recommendations as needed to functional areas.
Supports quality related needs of various departments (Operations, R&D, Manufacturing). This includes validation documentation, manufacturing process instructions and quality planning support.
Maintain various spreadsheets and databases for quality systems processes.

Documentation SpecialistJun 2011 - May 2015
Boston ScientificQuincy, MA

Document and Change Control: Coordinates the review and revision of documentation submitted on Change Requests according to internal and regulatory policies and procedures; prioritize weekly document processing tasks; run metrics that track Department Performance and trending; copy, distribute and maintain documents in accordance with company procedures; review final version of documentation changes for any potential issues and work with team to resolve any issues.
Record Control: Store and maintain all quality records, policies and procedures required for compliance according to internal and regulatory policies; utilize imaging systems to archive documents electronically.
Recommends changes to policies and procedures and systems relevant to document and record storage and handling; implement changes for increased security, efficiency and accessibility while adhering to all internal and regulatory policies and procedures.
Certified site and corporate trainer of current documentation system (PDM).
Participate in cross functional teams for LEAN initiatives and process improvement projects; evaluate new processes and procedures to be used in Document Control.
FDA, TUV, and Internal Audit Support (including front room).

Customer Services/Returns RepresentativeJun 2008 - Jun 2011
Boston ScientificQuincy, MA

Process and confirm customer medical device orders for all Boston Scientific Divisions received from customers via fax or telephone.
Triage incoming fax orders and handle as appropriate (e.g. enter orders, forward faxes to other departments as appropriate, delete junk faxes, etc.)Input order information into SAP order entry system.
Provide substitute alternatives and availability dates for back-ordered products.
Acknowledge order and provide pertinent text to customer via SAP.
Provide training to new customer services representatives, developing my own training material.
Perform duties while meeting expectation set for the availability metrics and accuracy metrics. Perform all duties within the Job Specific SOP requirements.
Track shipments for customers. Contact the Freight carrier or utilize the Internet to obtain delivery information and provide either verbal or hard copy delivery receipt information.
Work closely with the Distribution department to provide detailed information on short shipments or lost shipments.
Handle emergency situations for customers.
Call within the corporation including distribution, marketing, sales management and other departments to obtain answers and solutions to customer requests.
Assists sales representatives in the field with returning and exchanging products.

Junior Quality Assurance AnalystJun 2006 - Mar 2008
Computer Share Fund Services (contracted)Canton, MA

Monitored calls for quality assurance made by customer services representatives, regarding proxy voting on mutual funds.
Supervised 3 to 5 analysts in their quality review of calls made
Presented a quality presentation to new hires on the quality departments expectations in regard to their interaction with customers
Participated in the interview screening process for new hires
Called Shareholder\'s back to correct information when a quality error was found

Education

Bachelor of Science: 2009
Bridgewater State CollegeBridgewater, MA

Resume Overview

Companies Worked For:

Boston Scientific
Computer Share Fund Services (contracted)

School Attended

Bridgewater State College

Job Titles Held:

Senior Documentation Specialist
Documentation Specialist
Customer Services/Returns Representative
Junior Quality Assurance Analyst

Degrees

Bachelor of Science : 2009

Senior Documentation Specialist Resume Example

Resume Score: 80%

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