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Senior Documentation Specialist Resume Example

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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 Specialist May 2015 - Current
Boston Scientific Cambridge, 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 Specialist Jun 2011 - May 2015
Boston Scientific Quincy, 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 Representative Jun 2008 - Jun 2011
Boston Scientific Quincy, 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 Analyst Jun 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 College Bridgewater, MA

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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

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