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 | Windchill, PLM, Arena |
Work History
Senior Documentation SpecialistMay 2015 - Current
Iconma, L.L.C.Morrisville , NC
Iconma, L.L.C.Morrisville , NC
- 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
UpstartAtlanta , GA
UpstartAtlanta , GA
- 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
LithicSan Francisco , CA
LithicSan Francisco , CA
- 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)City , STATE
Computer Share Fund Services (contracted)City , STATE
- 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 CollegeCity, State
Bridgewater State CollegeCity, State
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Resume Overview
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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