Carol Hicks, CQA

Experience

• 

  Environment One Corporation

  Dec 1990 - Oct 2007

  Buyer and Customer Service Specialist

  As a Buyer, responsible for day to day purchase of MAPICS generated component needs and Material Requistion forms. Communicated quickly and effectively with the necessary departments to maximize productivity and minimize customer dissatisfaction.As a Customer Service Specialist, priority was placed on the resolution of problems and complaints to increase customer satisfaction.

• 

  The Bashor Connection

  Nov 2007 - Sept 2008

  Real Estate Broker Assistant

  Worked with Buyers and Sellers to ensure a smooth journey to the closing table

• 

  Ericsson

  Sept 2008 - Jan 2011

  Doc Control Spec/Configuration Management

  CM LeadDocument Control SpecialistComprehensive Database ManagementProcess Advocate

• 

  Agilent Technologies

  Jan 2011 - Dec 2019

  Responsible for day to day purchase of both direct and indirect materials. Communicate quickly and effectively with suppliers and internal departments to maximize productivity and minimize customer dissatisfaction while strictly adhering to current Good Manufacturing Practices (cGMP) regulations and standard operating procedures (SOP).Evaluate and coordinate material requirements to ensure controlled flow of materialsMaintain, manage and reduce inventory to planned levelsFacilitate cost reductions while maintaining qualityWorked closely with planner, logistics, facilities, engineering, manufacturing, and accountingExpert knowledge of ERP SAP (direct materials) and SAP Ariba (indirect materials) as well as SysProProblem solving and relationship building with suppliers and internal customers Show less Manage Document Control activities per Good Manufacturing Practices (GMP) regulations and proceduresMaintain document templates ensuring accurate execution of information during manufacturing (Mfg) processes and operations, specifically ensuring consistency in content and format among batch records of the same client and incorporating document updates that affect all master batch records for clients at development levels. Review and coordinate the completion and assembly of batch record packages for Mfg and/or Quality review. Adhere to the guidelines of cGMP regulations and SOPs as well as international regulations (International Conference on Harmonisation or ICH). Part of successful FDA audit! Show less

  • Material Procurement Senior Buyer

    Jun 2016 - Dec 2019

  • Manufacturing Document Control / Quality Rep

    Oct 2014 - May 2016

  • Document Control - Team Lead/Supervisor

    May 2012 - Sept 2014

  • Document Control Specialist

    Jan 2011 - Apr 2012
• 

  ArcherDX, Inc.

  Jan 2020 - Sept 2020

  Document Control and Quality Assurance Specialist III

  Responsible for both the management and control of documentation using the Greenlight Guru (GLG) system and also for Quality Assurance Manufacturing floor support. Communicate quickly and effectively with all departments with regard to documentation lifecycle in the GLG system and also for Batch Record review and approval as well as Manufacturing floor support all while adhering to current Good Manufacturing Practices (cGMP) regulations, medical device guidelines and regulations and standard operating procedures (SOP).Manage and maintain a GMP-compliant document management systemPlans, executes and ensures controlled documents are managed per SOP and applicable regulations Maintains hard copy and electronic controlled documents in accordance with applicable proceduresManaged the GLG system according to procedures and appropriate regulationsActs as Subject Matter Expert (SME) for both Document Control and Quality Assurance (QA)Represents Document Control and QA in internal meetings and site auditsDevelops and tracks goals and facilitates continuous improvements of GLG as well as QAProblem solving and relationship building on various projects as necessary always ensuring appropriate control of documentation is maintained Show less

• 

  Aktiv Pharma Group

  Sept 2020 - Mar 2024

  • Document Control / Quality Assurance Manager

    Feb 2023 - Mar 2024

  • Supervisor, Document Control

    Sept 2020 - Feb 2023
• 

  Colorado Judicial Branch

  May 2024 - Jun 2024

  Contract Judicial Court Assistant

  JCA assisting Self-Represented Litigant Coordinator with the management and coordination of Small Claims Mediations. Solicits and provides internal and external resources to pro se litigants.

• 

  Williams

  Jul 2024 - Sept 2024

  Document Controller/Specialist III

  Accountable for the implementation of existing document control specifications.Accountable for tracking Engineering, Contractor and Vendor deliverables throughout the project lifecycle (recording revisions, revision purposes, distribution and transmittal histories).Accountable for the reliability, retrievability and traceability of the project data that is officially transmitted to and from Williams and in accordance with the Document Control standards and specifications.Process incoming and outgoing correspondence in a timely manner.Generating and updating each Supplier's and Contractor's Document Register in a timely manner (e.g., incoming, outgoing and squad checking processes)Ensuring that each applicable metadata field is accurately updated and maintained in each Document RegisterPreparing and implementing documentation in accordance with procedure and distribution matrices.Preparing accurate status reporting based upon the metadata designations and submitting at the determined frequency (per project basis).Aligning with the Document Control standards and ensuring any deviations due to project-specific needs are controlled and traceable. Show less

• 

  Medtronic

  Oct 2024 - now

  Project Coordinator III

  Routes key documents into a document control system and help maintain project design history file. Ensures DHF contains all docs created during the product development phase of medical device. Follows standard operating procedures and understand criticality of quality compliance.Performs a variety of complex or technical-advanced administrative and clerical duties with a high degree of initiative.