Deborah Duvall - page *

Deborah Duvall

Wyomissing, Pennsylvania, United States

ad3h5n@r.postjobfree.com

610-***-****

Career Summary

Quality Assurance Documentation Management Professional experienced in the Consumer Health, Pharmaceutical and Medical Device Industry.

Perform effectively and efficiently with extensive experience in document change management with excellent interpersonal communication skills of all levels of internal, external Change Requestors and Subject Matter Expert’s

(SMEs), including management, clients, and medical staff with discretion, both written and verbal throughout the lifecycle of a change.

Recognized for strong interpersonal/organizational skills and multi-tasking abilities in high-level documentation roles within highly regulated industries with focus on excellent customer service while committed to building trusting relationships and fostering a positive workplace culture as a team member supporting team goals and objectives.

Demonstrate initiative and self-motivation with the ability to perform autonomously as well as a team in fast-paced environments while adhering to project deadlines.

Strong attention to detail, proofreading, formatting, record management with the understanding of office procedures and work instruction.

Quality conscious, adhering to the Quality Management System (QMS) procedures and quality objectives.

Extensive experience with managing effective Electronic Quality Management System (eQMS) fulfilling responsibilities based on Quality System Regulation (QSR), ISO 13485:2016, ISO 9001:2015 and FDA Regulations within Medical Device and Pharmaceutical environments.

Trained in/working knowledge and experience with Cleanroom Procedures and Hazcom/Hazmat. Experience

Documentation Specialist Change Analyst

Teleflex

May 2017 - Present

Vascular - Review change management activities for adherence to applicable change management procedures and cross-functional approval levels. Site coordinator as Change Analyst / Data Steward ensuring data and documentation is maintained and aligned across the Product Lifecycle Management (PLM), eQMS using Agile to prepare, process, maintain and support Devise History Files (DHF), Device Master Record (DMR), Work Instructions (WI), Form Control Documents (FCD), ECOs, MCOs. EXPs, OROs, ADCs and ECRs. Processing of Standard Operating Procedures (SOP’s), Bill of Materials (BOMs), Batch Records, Material Specifications, Product Specifications, Quality Records and Engineering Drawings/CAD. Lansa UDI systems for Global Trade Numbers

(GTINS) of Internal Part Numbers (IPNs) to ensure accuracy within document control processes and procedures in compliance with Medical Device Regulation (EU MDR) requirements while adhering to current Good Manufacturing Practices (cGMP), and Food and Drug Administration (FDA) Guidelines. Review and proofread documents for errors, clarity, standardize format, verify configuration, and perform related data entry in coordination with Engineering and Regulatory Teams. Training of Document Control processes within Learning Management System (LMS) ComplianceWire system. Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures, and housekeeping standards. Deliver consistently high-quality service and solutions that meet business requirements and ensure goals are accomplished in line with business objectives. Share ideas, information, knowledge, and data proactively to accomplish collaboration for the success of the team, project, or task. Deborah Duvall - page 2

Document Control Specialist

DePuy Synthes

Jan 2015 - Jan 2016

Maintain Device Master Record (MDR), Change Orders/Notices, product drawings, process sheets, inspection sheets, tool, gauge, fixture drawings, routings, and BOMs. Process manufacturing changes by checking packages for accuracy, assigning change numbers, distributing documents for drafting, releasing final documents both hardcopy and electronic. Coordinate product change order related activities which include the processing of text- based changes. Data entry into JDE, Windchill, DocusPhere, CDR and FlexQ systems. Perform filing and support the imaging/verification process for QSR. Coordinate product complaint handling. Maintain and improve Quality Standards and processes within the department while working with Production and Engineering to ensure compliance with procedures and QSR standards. Liaison for retrieving documentation to support external audits. Establish and maintain employee training records via hardcopy and electronic. Document Coordinator

Perker Hannifin

Jan 2012 - Jan 2013

Change Control Management of procedural documentation and Electronic Change Notice (ECNs) through the Quality Documentation System ensuring all in compliance with the document control requirement and systems integrity. Notes based QSI, ERP System and oversight of change control activities including implementation, re- establishment, re-organization, re-numbering, re-creation, and new revision sequence level. Redlining and updating of the Quality Manual, Manufacturing, Engineering, and Quality Procedures for the entire plant site in correspondence with all stakeholders. Documents include calibration and equipment Preventive Maintenance

(PMs). Re-organization of controlled documentation ensuring an effective and comprehensive Documentation Master Listing is put in place for an effective quality system with quality concepts. Organization of documentation, update process, approval process and the identification of obsolete documentation and removal for filing and archiving. Ensure current document revisions are readily available for various files including SOPs, WI’s, FCD’s, Routers, Drawings and circulate as required to the appropriate stakeholders such as Quality, Lean Group, Engineering, Customer Service, Procurement, Shipping, Operation and Manufacturing. Review and inspection of Batch Records and certificate of conformance and assisting in setup of the packets for upcoming Audits. Senior System Administrator

Stryker

Jan 2011 - Jan 2012 (1 year 1 month)

Divisional responsibility for computer systems configuration management and administration systems. Ensure overall compliance with document control requirements and systems data integrity while following regulatory requirements: ISO 9001, QSR and Medical Device Directive (MDD). Support activities for process improvements and systems integration projects. System administration and divisional change control activities for procedural processing of ECNs, ECOs and procedural documentation through document change control management systems with personnel in US and international within all disciplines. Item creation, maintenance activities and independently troubleshoot issues with the ERP system. Train users on systems and processes within the electronic environment.

Training Coordinator

Teva Pharmaceuticals

Jan 2010 - Jan 2011

On-going maintenance of the training for site manufacturing operations. Provide administration of (LMS) including Deborah Duvall - page 3

the tracking and coordination of documents and training required. Partner with Initiator / Owners to determine training assignment and delivery for new and revised documents. Develop and maintain curricula for personnel. Provide user support for the LMS. Coordinate training with management and Qualified Trainers (QT). Provide ongoing support for training related inquiries. Generate training compliance reports. Document Coordinator

KENSEY NASH CORP.

Jan 1999 - Jan 2009

Technical writing, document formatting and word processing from redline and track changes of documentation. Initiate documentation control functions throughout the documentation lifecycles. Build and perform product Bills of Material (BOMs) update, maintain and control various files including CAPA’s, NCs, DHF’s DHR’s, NCR’s ECN’s and ECR’s, within the Windchill and Oracle Inventory System and maintain update, and track all appropriate documentation files and Quality/Regulatory library files of all originals. Assign new and obsolete part numbers, update, process and track SOPs, routers, forms, CAD drawings, create templates, and circulate as required. Distribution, and maintenance of internal procedural documentation and records indexing, archival, retrieval, and maintenance of product specification, DMFs, and DHFs. Maintain compliant files, Return Authorizations

(RA), suppliers files, distributor files, customer files, non-conformance, Corrective Preventive Actions CAPA and calibration/ (PMs), and tooling files.

Education

Montgomery Community College

General Business

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