Candace Hagood

Experience

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  Candace’s Gift Boutique

  Jan 1991 - Jan 1997

  Family Business

  Family BusinessSmall family gift boutique.Learned basics of customer service, bookkeeping and handling shipments on a daily basis.

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  Bristol-Myer Squibb

  May 2005 - Apr 2006

  Administrative Assistant and Records Manager

  Responsibilities: Issued, distributed and tracked laboratory notebooks. Performed regular audits of internal records keeping systems. Maintained communication with imaging service vendors. Accomplishments: • Reduced incomplete data records by 50% using “Omni Rim” and “Pi Keywords” records databases.• Managed shipping and receiving of proprietary records. • Provided user training for tracking software. • Corresponded with vendors to track progress and schedule projects. Show less

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  Daiichi Sankyo Pharma Company

  May 2006 - Sept 2007

  Clinical Records Management Associate

  Responsibilities: Assisted in the development of a pharmaceutical records center based on ICG, GCP, MHRA and FDA regulations. Responsible for the organization and processing of clinical trial documentation including Phase I, II and III trial master files. Communicated with CRAs and CROs to ensure of trial master files. Provided remote training new employees in US and UK offices. Accomplishments: • Led large file conversion from paper based to an electronic, barcode-based RS-SQL system. • Successfully collaborated to develop center training manual. • Provided ERM training to both document center and external employees.• Worked with vendors and CRO to streamline a process for document submissions. Show less

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  Smith & Nephew Biologics (formerly Healthpoint)

  Mar 2008 - May 2015

  ECM / Document Center

  Enterprise Content Management Responsibilities: MasterControl -Management in the evaluation, acquisition, development and validation of enterprise Electronic Document Management System (EDMS) and associated Training Management Tool.- As system administrator, conducted requirements gathering both domestically and international.- Completed electronic records migration of over 15,000 line items and task events from several legacy systems into a validated QMS software. - Perform extensive business process analysis/mapping in support or requirements gathering.- System validation activities including writing and execution of validation protocols (IQ, OQ, PQ), final reports and supporting standard operating procedures. Sculpted testing methodology to be used for multi-site implementation. - Planning for integration with ERP system.- Responsible for system configuration and software change management.- Developed end user training via interactive tools, Macromedia Captivate and Adobe Flash based solutions and classroom training. - Provided RIM focused employee training and guidance.Records Management Responsibilities:- Worked closely with functional areas to develop a company-wide document center. - Provided RIM focused employee training and guidance. - Created task specific standard operating procedures (SOPS) outlining daily activities within the center.- Collaborated with functional areas to create file classification schemes. - Successfully organized company-wide program launch and training activities.- Developed several MS Access databases in functional areas to support information management initiatives. - Extensive VBA and MS SQL coding.- Designed several easy-to-use end user interfaces with custom reporting.• Responsible for initial supplier qualification.• Quality document change control process.• Involved in the interviewing process of new employees and temporary staffing.• Trained and supervised long term temporary employees. Show less

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  ARMA LEADERSHIP

  Jan 2013 - May 2015

  CHAPTER VP Professional Development
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  MasterControl

  May 2015 - now

  Professional Services Manager

  • Senior member of a fast-paced team environment geared towards providing high quality services to a broad customer base.• Leading global customers in configuration, validation and overall implementation of regulated QMS systems.• Educating customers in industry Best Practice applications of company products.• Expert use of MasterControl Suite including Documents, Training, Process (Enhanced Form and eForm), Electronic Batch Records (Mx), Bill of Materials, Audit, Supplier, Risk, eTMF Manager and Jumpstart, Registrations, and Project Modules. • Performing process analysis with prospective customers to evaluation product and resourcing requirements.• Preparing and delivering proof of concept demonstrations with new and upgrade prospects.• Delivering customer-facing product education services.• Identifying potential project risk and mitigation actions.• Ownership of customer issues working with internal and external resources to address across multiple divisions within MasterControl to ensure successful implementations. • Providing customers with industry Best Practice consultation for development of quality systems.• Conducting Validation (VxT) education. Developing validation documentation in conjunction with Validation Excellence Tool (VxT)• Risk Assessment and TOQ Reporting, Performance Qualification and UAT (User Acceptance Testing)• Communication of critical findings from fieldwork back to the appropriate MasterControl team members. Show less