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.
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
Senior Documentation SpecialistMay 2015 - Current 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
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.
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.
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
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
and confirm customer medical device orders for all Boston Scientific Divisions
received from customers via fax or telephone.
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.
substitute alternatives and availability dates for back-ordered
Acknowledge order and provide pertinent text to customer via SAP.
Provide training to new customer services representatives, developing my own training
duties while meeting expectation set for the availability metrics and accuracy
metrics. Perform all duties within the Job Specific SOP requirements.
shipments for customers. Contact the Freight carrier or utilize the Internet to
obtain delivery information and provide either verbal or hard copy delivery
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
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
Bachelor of Science: 2009 Bridgewater State CollegeCity, State
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Bridgewater State College
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Bachelor of Science : 2009
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