Summary
Work History
Education
Skills
Additional Information
State
Zip
Quote
City
Software
Languages
Interests
Timeline
OfficeManager
Tiffany Eason

Tiffany Eason

Princeton,NC

Summary

Detail-oriented Sr Documentation Specialist with a solid record of success in Manufacturing with over 10+ years of experience. Knowledgeable about organizing files and workflows according to company, client, and project specifications. Desiring to apply expertise to challenging new role with your company. Results-oriented with focus on producing quality work and meeting deadlines. Organized and motivated employee eager to apply time management and organizational skills in various environments. Seeking mid-level opportunities to expand skills while facilitating company growth.

Work History

Sr. Documentation Specialist

Fresenius Kabi USA LLC
01.2024 - Current
  • Produced on-time communications in support of navigating from Documentum to eDMS.
  • Established, improved and reinforced document management systems to handle current and expected requirements.
  • Collaborated with quality assurance team to comply with regulatory requirements.
  • Provided assistance with inbound and outbound document processes, document sorting, logging, and work order creation.
  • Compared incoming data against quality, integrity and accuracy expectations, identified faults and affected timely remedies.
  • Managed regulatory requirements and audit support needs by completing and submitting accurate paperwork.
  • Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
  • Maintained organized and efficient document flows by using excellent planning and multitasking skills.
  • Managed file archival and information retrievals.
  • Identified areas of weakness and recommended or implemented process improvements.
  • Assist with establishing and maintaining a new filing system for Microbiology legacy documentation as well as outstanding documentation.
  • Assist with establishing a new documentation filing system for the QA documentation vault/central file storage area as well as a spreadsheet tracking tool.
  • Eliminated outstanding backlog of Iron Mountain documents that are currently present in the QA Documentation Vault.
  • Primarily responsible for document issuance in both Documentum and eDMS for support of microbiology, chemistry, IQC, and site stability programs.
  • Reviewing and editing documents for accuracy and completeness

Documentation Coordinator

Fresenius Kabi USA LLC
10.2017 - 12.2023


  • Assisted Sr. Documentation Specialist with Documentum training of site personnel
  • Provided input on preparation and writing of SOPs for document control
  • Assisted in the revision and update of procedures
  • Maintained and issued Production Unit logbooks and laboratory notebooks to ensure the logbooks followed all applicable procedures prior to being archived
  • Coordinated issuance and reconciliation of controlled laboratory documents
  • Assisted in the issuance of Production Batch Records
  • Worked with Compliance team on records and reports that were subject to FDA/cGMP inspection
  • Support and participated in Community Involvement activities internal and external
  • Assisted with record management activities, including archive maintenance, coordination of documents and on and off-site storage
  • Ensured overall quality, completeness, and delivery of customer documentation request through departments.

Document Controller

Mindlance, Inc, GlaxoSmithKline
06.2016 - 03.2017
  • Assisted Site Compliance with 12, 24, and 36 month reviews
  • Verified effective DELTA documents with the backup drive and verify version 1.0 procedures are on the SOP Matrix
  • Verified procedures that were obsolete were removed from backup drive and SOP Matrix
  • Reported percentage of overdue weekly and monthly SOPs
  • Made minor changes to document revisions and update history of change
  • Created new employee file folders and perform necessary filing
  • Booked conference rooms for Disciplinary Policy Training
  • Updated and maintained accurate data in the document control database and provided support to Site Compliance team, Create and issue weekly NFF Document Reports
  • Sent out email notifications to Project team
  • Created and tracked email notifications during initial review process for Regulatory Submission documents
  • Issued and logged forms for routing and approvals
  • Issued cancellation memos to Validation department when document numbers are no longer needed or either duplicate request
  • Ran database queries each week for new commissioning documents
  • Logged discrepancies in spreadsheet for weekly reporting
  • Documentation of Site Training, Production, (Pkg, Mfg, MDPI) and Quality
  • Documentation Auditor
  • Filing of Critical Documentation
  • TROL Administrator: (Training Records On-Line) Employee Profile Maintenance (new hires, terminations, relocations, position changes, etc.)

Job Coach Pool

Johnston County Industries, Inc
03.2016 - 10.2016
  • Provided one-on-one training and job coaching to clients placed on jobs in community
  • Supervised and instructed client(s) according to established curriculum
  • Maintained contact, communication with involved parties
  • Continually assesses participant's work performance and maintains required documentation
  • Adhered to established schedules to assure client coverage
  • Promoted safety and ensures safe work environment for client(s)
  • Provided continued support and follow-up
  • Knowledge of job tasks to provide instructions to client
  • Maintained documentation of service delivery
  • CPR/First Aid Certified.

NFF Document Support Specialist

Grifols Therapeutics
09.2012 - 11.2014
  • Ensured consistency and accuracy for each document according to FDA guidelines
  • Maintained and updated documents for approval and execution in NFF tracking database
  • Facilitated and monitored circulation of documents for authorized signatures
  • Handled the task of scanning hard copies to create electronic copies
  • Created email notifications for initial review of Regulatory Submission documents in preparation for routing documentation
  • Issued change control forms when requested by engineers
  • Created and issued CCR Daily reports for Project team
  • Created and issued weekly NFF Document Reports
  • Created and tracked email notifications during initial review processes for Regulatory Submission documents
  • Issued and logged forms for routing and approving documents
  • Issued cancellation memos to Validation department when document numbers are no longer needed or either duplicate request
  • Ran database queries each week for new commissioning documents
  • Logged discrepancies in spreadsheet for weekly reporting.

Sales Associate

Talbots Outlet
01.2011 - 07.2014
  • Greeted customers, determine each customer's needs
  • Maintained knowledge of existing sales promotions, policies concerning payments and refunds
  • Answered customer's queries pertaining to merchandise and the store
  • Recommended items to customers as per their needs and preferences
  • Represented Talbot's as trusted style and fashion adviser
  • Shared relevant products information with customers: trends, inspiration, product knowledge and top 10 investment pieces
  • Asked questions, actively listened and repeated customer needs to check understanding to make relevant product choices
  • Escorted and assisted customers in fitting room
  • Explained loyalty benefits and invited customers to apply for a Talbot's charge
  • Helped the customer transition from decision making to purchasing
  • Worked with multiple customers, pass off customers to other associates and working with zone coverage
  • Interacted with customers to offer her a service experience with a sales result
  • Friendly, upbeat, and interested in her
  • Set-up merchandise for display
  • Customer service skills, organizational skills, and data management abilities.

File Clerk

Fluor/Grifols
05.2012 - 08.2012
  • Added new material to database records and created new records as needed
  • Assigned record and stamp commissioning document numbers to index materials for filing
  • Responsible for organizing, photocopying, and updating documents
  • Maintained confidentiality of documents
  • Typed indexes for sections of binders already assembled, typed labels for these sections, and applied labels
  • Compiled books / binders to complete in final product state.

Documentation Coordinator

Talecris Biotherapeutics
03.2011 - 07.2011
  • Assisted Procurement Office Services with the 2011 Vendor Cleanse Project
  • Researched active and inactive vendors for project
  • Contacted and updated vendor / supplier information
  • Determined if a vendor should be marked inactive in the last 2 years
  • Archived 2010 vendor supplier documentation
  • Searched for FedAch participants
  • Verified critical vendor / supplier information
  • Supported annual critical Procurement projects.

File Clerk/Accounts Payable Clerk

Talecris Biotherapeutics
12.2010 - 12.2010
  • Pulled and sorted invoices for audit.

PMO Admin Associate II

Talecris Biotherapeutics
10.2010 - 11.2010
  • Provided administrative support to Senior Director of Project Management Office
  • Arranged meetings, agendas, and follow ups for Senior Director
  • Reserved conference rooms for meetings
  • Prepared agenda and minutes for staff meeting
  • Assisted members in the Project Management Office group with other projects
  • Scanned confidential documents for Project Management Office department
  • Processed confidential and sensitive information in support of administrative activities
  • Maintained efficiency of departmental office operations
  • Reviewed, maintained, and reconciled departmental budgetary records.

Document Support Clerk

Talecris Biotherapeutics
06.2010 - 09.2010
  • Scanned and reviewed confidential documentation for Quality Validation and Engineering
  • Stamped approved protocols for execution
  • Routed documentation site wide
  • Processed and issued Validation document number request
  • Archived off-site documentation
  • Assisted Quality Validation and Engineering department with locating documents and protocols.

RSD Document Support Clerk

Talecris Biotherapeutics
04.2010 - 05.2010
  • Created section dividers, new binders, sort and file inactive Regulatory Submission documents final approval forms and file new documents
  • Completed summary of changes forms, pull inactive Regulatory Submission documents from binders
  • Scanned new and superseded inactive Regulatory Submission documents from email change control coordinator for closure of CCR
  • Audited inactive Regulatory Submission documents on Documentation Web and hard copy files
  • Consolidated Pre-approved binders
  • Organized Alpha 1-MP history documentation
  • Sorted and filed TRD/RSD history files for offsite storage
  • Filed (new) inactive Regulatory Submission document history
  • Assisted with inactive Regulatory Submission documents delivery and pickup as needed
  • Archived off-site documentation.

LMS Data Entry Support Clerk/Compliance Wire, Archiving Support Clerk

Talecris Biotherapeutics
09.2009 - 02.2010
  • Assigned security roles to users
  • Data Entry verification with Training Session Reports (TSRs) and Qualification summary forms
  • Generated Compliance Wire reports
  • Added recurring training assignments to users
  • Provided formal documentation to support regulatory, quality, and enterprise system training requirements, including instructor-led and e-learning format, structured on-the-job (OJT), trainer qualifications and checklist guides
  • Filed/Archived/Entered Training Session Reports (TSRs), Matrices, OSHA certificates, Turnaround evaluations
  • Pulled employees training documents for JCC Cohort Program
  • Edited users’ information, adding historical completions, and adding assignments
  • Provided centralized coordination of training policy, procedures and systems
  • Maintained Learning Management System (LMS) training environment and provide
  • Assisted in implementing a new Learning Management System for over 2000 employees.

Education

Bachelor of Science in Criminal Justice -

Strayer University
Raleigh, NC
12.2011

Associate of Science in Criminal Justice - undefined

Johnston Community College
Smithfield, NC
05.2007

Certificate, Travel & Tourism - undefined

Southeastern Academy
Kissimmee, FL
03.1997

Skills

  • Knowledge of GMP, GDP and pharmaceutical manufacturing
  • Electronic document preparation
  • File Management
  • Quality Assurance
  • File systems coordination
  • Document retrieval
  • Cross-Functional Collaboration
  • Communication Skills
  • Problem-solving aptitude
  • Document classification
  • Data Management
  • Document storage

Additional Information

Awards/Certificates: Certificate of Appreciation for Outstanding Performance with 2011 Vendor Cleanse Project Awesome Client-Site Employee for 2011 Vendor Cleanse Project Awesome Client-Site Employee for Completion of the Compliance Wire Launch

State

NC

Zip

27569

Quote

You will recognize your own path when you come upon it because you will suddenly have all the energy and imagination you will ever need.
Sara Teasdale

City

Princeton

Software

Documentum

EDMS

RAP

Languages

English

Interests

Photograpy

Floral arrangements

Volunteering

Travel

Timeline

Sr. Documentation Specialist

Fresenius Kabi USA LLC
01.2024 - Current

Documentation Coordinator

Fresenius Kabi USA LLC
10.2017 - 12.2023

Document Controller

Mindlance, Inc, GlaxoSmithKline
06.2016 - 03.2017

Job Coach Pool

Johnston County Industries, Inc
03.2016 - 10.2016

NFF Document Support Specialist

Grifols Therapeutics
09.2012 - 11.2014

File Clerk

Fluor/Grifols
05.2012 - 08.2012

Documentation Coordinator

Talecris Biotherapeutics
03.2011 - 07.2011

Sales Associate

Talbots Outlet
01.2011 - 07.2014

File Clerk/Accounts Payable Clerk

Talecris Biotherapeutics
12.2010 - 12.2010

PMO Admin Associate II

Talecris Biotherapeutics
10.2010 - 11.2010

Document Support Clerk

Talecris Biotherapeutics
06.2010 - 09.2010

RSD Document Support Clerk

Talecris Biotherapeutics
04.2010 - 05.2010

LMS Data Entry Support Clerk/Compliance Wire, Archiving Support Clerk

Talecris Biotherapeutics
09.2009 - 02.2010

Associate of Science in Criminal Justice - undefined

Johnston Community College

Certificate, Travel & Tourism - undefined

Southeastern Academy

Bachelor of Science in Criminal Justice -

Strayer University

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Tiffany Eason