Summary
Overview
Work History
Education
Skills
Websites
Certification
Workexperiencepriorto2013
Publishingtools
Timeline
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BRITTANY RICE

Summary

A strong Quality Assurance & Document Control Manager Professional with dedication to Pharma, Bio tech, and Medical Device companies; focused on new product development and technical projects, promoting high-quality standards to deliverables, and ensuring client satisfaction to completion. Strategic oversight, driving the success through managing projects, compliance & quality, CAPA, regulatory, technical writing, IT application/systems, document management and control, user training combined with 20-plus years of resilient self-driven abilities.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist (CAPA/Supplier Management)

Fujifilm
Lexington, MA
01.2022 - 08.2024
  • Lead document control supported remediation projects
  • Initiated CAPAs globally and managed investigations in the CAPA system for non-CAPA organizations
  • Collaborated with crossed functional teams using investigational tools to determine the root cause of any non-conformity, ensured CAPA plans address root causes, and CA/PAs implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems
  • Ensured that effective actions processed on time, detailed, and completed
  • Meet the business and customers required standards and/or procedural requirements
  • Evaluated and completed activities in the CAPA systems, included effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from the division's Quality System
  • Monitored daily change reports and adjusted LMS and eQMS data
  • Facilitated the investigation process to ensure that root/potential causes are appropriate and implemented effective actions to reduce the occurrence/recurrence of the nonconformance
  • Ensured team effectiveness by demonstrating full cross-functional team support that complies with corporate and regulatory requirements
  • Teamed up with Salesforce supplier change control
  • Ensured harmonized and consistent change control processes to provide guidance/direction regarding execution
  • Performed supplier management, internal audits reviewed, revised, and routed documents within EtQ system

Manager Document Control/System Admin

SkinCure Oncology
Burr Ridge, IL
10.2023 - 06.2024
  • Company Overview: the national leader in the delivery of superficial radiation therapy services, referred to as Greenlight Guru
  • Lead document control manager and system admin of regulatory affairs/quality assurance
  • Provided support on Audit readiness
  • Implemented the company’s eQMS system for SkinCure Oncology
  • Created and implemented SOPs
  • Managed, migrated legacy documents, paper-based documents, and downtime logs from Salesforce to eQMS
  • Reviewed, approved, and archived documentation
  • Maintained department SharePoint
  • Managed CAPAs, change control, and complaints
  • Assured initiation, classification, closure, and effectiveness evaluation of deviations and CAPAs timely
  • Maintained user account and supported system activities
  • Reviewed issues reported by users and assigned appropriate resources for resolution
  • Resolved access issues for end users, any ticketed issued
  • Supported digital system’s strategic tasks and ensured continuous improvement efforts
  • The national leader in the delivery of superficial radiation therapy services, referred to as Greenlight Guru

Document Control/CAPA Lead

Enovis
Wilmington, DE
09.2022 - 08.2023
  • Performed internal audits to MDSAP requirements related to medical devices
  • Assured timely initiation, classification, closure, and effectiveness evaluation of deviations and CAPAs
  • Assisted with QMS integration of an acquired company
  • Migrated over 1500 legacy documents, archival and approval of documentation in the Greenlight Guru eQMS
  • Evaluated documentation and operations according to company procedures and understood basic word processing, presentation, and spreadsheet application skills
  • Used AutoCAD for all drawings and models
  • Managed drawing revisions
  • Reviewed and approved the following records in support of operations: Deviations, SOPs, Protocols, Technical Documents, Change Control, and training curriculums
  • Updated, reviewed, and approved the Bill of Materials (BOM), and drawings/diagrams
  • Supervised document control contractors

Document Control Manager

Peerbridge Health Inc.
Manhattan, NY
08.2017 - 12.2021
  • Document control manager of the Regulatory Affairs/Quality Assurance pillar oversight of projects from kickoff
  • Managed departmental document Control activities, supervised nine internal employees and contractors
  • Collaborated with key stakeholders Engineers, QMS, Doc Control to implement new SOPs, DOPs, WI, PRT, Packaging, Labels, and Protocols to govern related to their systems
  • Used AutoCAD for all drawings and models
  • Managed drawing revisions in Windchill
  • Migrated over 150 legacy documents, archival and approval of documentation
  • Initiating ECOs and assigning ECO numbers
  • Monitored daily change reports and adjusted LMS and eQMS data accordingly
  • Managed CAPA and Complaint Logs
  • Implemented a new numbering system and the control of editable versions of controlled documents
  • Promotion of Design Controls involving controlled documents
  • Ensured training records and matrices are in adherence with applicable regulations and are inspection ready
  • Performed metrics, system auditing, document Review, and gap assessments
  • Authored and redlined existing documents or assisted user with the redline process
  • Maintained the system for records and retention using a standard categorization system in accordance with the internal and regulatory requirements
  • Received and responded to requests for Quality Documents / Records / Revision History during internal and/or Regulatory Audits
  • Processed owner for complaint handling
  • Completed complaint investigations
  • Requested the review of new or changed documents by the authorized approvers
  • Maintained organization of the eQMS and controlled quality records such as the DHF, DMR, and TF
  • Assistance with reporting at Management Review meetings
  • Conducted training and Design Review meetings

Document Control & Technical Writer Manager

Zimmer Biomet
Warsaw, IN
02.2017 - 08.2017
  • Ensured harmonization of Projects
  • Managed Document Control activities and was responsible for the supervision of 25 internal employees and contractors
  • Collaborated with key stakeholders Engineers, QMS, and Document Control to revise and/or create new SOPs for their processes, systems
  • Supported project activities for the client's Quality Management System integration combining two Quality Systems into one due to a merger and ISO 13485:2016 updated QMS procedures to reflect the changes in the 2016 version of ISO 13485 transition plans
  • Collaborated with key stakeholders Engineers, QMS, Doc Control to implement new SOPs, DOPs, WI, PRT, Packaging, Labels, and Protocols to govern related to their systems
  • Initiated ECO's and assigned ECO numbers, processed new or changed documents into the QMS

Senior Quality Consultant

Valeant
Bridgewater, NJ
03.2016 - 02.2017
  • Consulted Pharmaceutical company that facilitates the review, collection, and/or development of Master Batch Records/Specifications for applicable Rx, Medical Device, OTC, Cosmetics, and Nutritional products
  • Allocated all current, approved Master Batch Record's (MBR) for their products (Rx, OTC, Cosmetics, Nutraceuticals, and Medical Device
  • Performed Gap Assessments
  • Ensured the quality of Packaging/Labeling
  • Created an eTMF for all batch records and specifications in SharePoint, attached to change controls that were then migrated into Documentum
  • Collaborated with sites and corporate team locally to create/edit/review/approve and archive MBR's for each product into
  • Work in partnership with a translation Company to translate master batch records/specifications from various languages to English
  • Generated weekly/monthly reports and periodic reviews
  • Decision making: Assessed situations to determine the importance, urgency, risks, and ensured are timely in the best interests of the organization
  • Organized: Set priorities, develop a work schedule monitor progress towards goals, and track details/data/information/activities
  • Planned: Determine strategies to move the organization forward, set goals, created, implemented action plans, and evaluated the process and results
  • Solved Problems: Assessed problematic situations to identify causes, gather and process relevant information, generated practical solutions, and made recommendations and/or resolved the problem

Quality Systems Specialist/System Admin

AbbVie
North Chicago, IL
01.2015 - 03.2016
  • Lead remediation projects
  • As the Quality System Specialist/Systems Administrator edited policies, processes, procedures, work instructions, user guides, and job aids
  • Provided cross-functional support for Quality Management Systems and Quality Department functions
  • Developed training curriculum (modules) and performed Gap Assessments and Assessed training plans
  • Migrated over 580 legacy documents, archival and approval of documentation
  • Issued document numbers, and created, tracked, and closed change orders
  • Managed Supplier Change Notifications
  • Completed change management assessments
  • Read, copied or proofed to detect and correct errors in spelling, and punctuation
  • Managed the document development and change request process for multiple documents simultaneously
  • Documents change control- facilitates change requests throughout their lifecycle from initiation through approval – within a controlled document management system
  • Ensured that quality system documents are correctly formatted, completed, and properly maintained

Corporate Document Control Manager

DePuy Synthes, J&J
West Chester, PA
05.2013 - 12.2014
  • Integration & Remediation Projects managed Document Control department activities and was responsible for the supervision of 17 internal employees and contractors
  • Change Request-DCO (Document Change Order) processing and final release globally for a medical device company that manufactures classes II and III medical devices that are used for trauma implantable, and surgery
  • Migrated over 1000 legacy documents, archival and approval of documentation
  • Created change requests and document updates on time
  • Ensured and maintained documentation format/template standards and requirements
  • Generated Training Assessments/Plans
  • Managed various projects for multiple workstreams
  • DCO (Document Change Order) coordination, approval signature validation, release activities-eTMF and final release verification and notifications
  • Document Number Issuance
  • Used AutoCAD for all drawings and models
  • Managed drawing revisions in Windchill
  • Assisted with cross-work stream inter-document impact assessments and Supplier Change Notifications
  • Tracked and trended lead times for document change control requests
  • Processed change requests and document updates promptly

Education

BSBA -

Colorado Technical University
Colorado Springs, CO
05.2014

Skills

  • Change Management
  • EQMS
  • Software Development
  • KPI’s
  • Document Control
  • CAPA/Auditing
  • Regulatory Submissions
  • GxP
  • Complaint Handling
  • Supplier Quality
  • Quality Assurance Training
  • System Administrator
  • Continuous Improvements
  • Regulatory Affairs
  • DHF/Design Review
  • Engineering Drawings
  • Risk Management
  • Batch Records
  • Document migration/ implementation/remediation/harmonization
  • Validation
  • CGMP
  • Technical Writing
  • EU MDR Regulations
  • Post Market Surveillance
  • FDA
  • Global regulations and standards: 21 CFR Parts 803, 806, and 820
  • IVD

Websites

Certification

  • CQA, Ongoing
  • ISO 13485:2016, 2022
  • MDSAP, 2021
  • ISO 17025:2017
  • Project Management, 2016
  • ISO 9001, 2010-2015
  • ISO 14971

Workexperiencepriorto2013

Available upon request.

Publishingtools

  • Frame Maker
  • Adobe Products
  • Photoshop
  • Google Forms
  • Google Drive Approvals
  • DocuSign
  • Creating DocuSign Forms

Timeline

Manager Document Control/System Admin

SkinCure Oncology
10.2023 - 06.2024

Document Control/CAPA Lead

Enovis
09.2022 - 08.2023

Quality Assurance Specialist (CAPA/Supplier Management)

Fujifilm
01.2022 - 08.2024

Document Control Manager

Peerbridge Health Inc.
08.2017 - 12.2021

Document Control & Technical Writer Manager

Zimmer Biomet
02.2017 - 08.2017

Senior Quality Consultant

Valeant
03.2016 - 02.2017

Quality Systems Specialist/System Admin

AbbVie
01.2015 - 03.2016

Corporate Document Control Manager

DePuy Synthes, J&J
05.2013 - 12.2014

BSBA -

Colorado Technical University

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