Nichole Early

Experience

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  Fullerton Genetics Lab

  Aug 2005 - Aug 2007

  Medical Practice Specialist

  • Performed medical and administrative functions for doctors' office and genetics clinic• Greeted patients, answered phones, and scheduled appointments• Processed insurance and performed ICD9 coding as part of administrative duties• Collected and entered patient data into state statistical database • Ensured accuracy of patient records, ensuring privacy of patient records, maintaining electronic medical record and archived patient files in accordance with record retention policies. Show less

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  Interstate Blood Bank, Inc.

  Jul 2007 - Dec 2014

  • Assigned to lead management/production of blood bank for manufacturing of injectable medications.• Handled and resolved all donor complaints appropriately while ensuring quality customer service.• Led in recruiting, hiring, training (administrative and clinical development). Reviewed and administered disciplinary actions, terminations, and employee records. Managed administrative and clinical staff of 50 employees.• Worked alongside production employees in areas, including: medical assisting, donor screening for suitability, quality assurance, phlebotomy, training, shipping and receiving, and lab processing.• Ordered inventory and monitored adequate temperature and compliance of medical supplies, including: Epinephrine, Benadryl injections, Heparin, Sodium Citrate and other medications.• Continually traveled throughout the region to other blood bank locations – providing training leadership.• Developed/implemented strategic and tactical plans to increase donors per day and to grow the business. Increased production from 70 donors per day to 140 donors per day through implementation of efficient procedures, training, marketing, and improved customer service.• Efficiently responded to compliance reports and regulatory observations as appropriate for situations.• Performed CBER FDA reporting, FDA safety reporting, and tracking of blood pharmaceutical products. Show less • Demonstrated ability in hosting and responding to regulatory audits for various pharmaceutical companies, international regulatory agencies, FDA, and state-mandated regulatory agencies.• Ensured compliance with equipment qualification, calibration and requalification procedures, and timelines.• Managed corrective actions and customer response to pharmaceutical complaints and nonconformance.• Managed test results and product shipments to ensure quality product was delivered to pharmaceutical manufacturing or fractionation plants following customer operating procedures and regulatory compliance. Show less

  • Center Manager

    Sept 2007 - Dec 2014

  • Quality Assurance Coordinator

    Jul 2007 - Sept 2008
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  Owens and Minor

  Jan 2015 - Mar 2020

  Quality/Compliance Manager – Custom Procedure Solutions

  • Responsible for regulatory and quality management for US Custom Procedure Solutions division, including Private Label OR products and medical procedure kits and trays. Lead teammates and resources involved in legal and regulatory compliance issues, such as research and regulation interpretation.• Develop and implement appropriate solutions to address quality and compliance gaps upon discovery.• Lead Federal Drug Administration (FDA) and other regulatory body audits/meetings including customer audit facilitation. Respond to agency inspections and other follow-up activity requirements.• Manage and implement risk management processes. Establish and facilitate quality objectives for sites. • Monitor progress of business against quality compliance goals and objectives through KPI metric reviews.• Plan development and management for quality and compliance continuous improvement projects.• Provide direction and revise procedures and work instructions to support quality improvement efforts.• Review and initiate quality, supplier, and customer contracts in relation to regulatory compliance. • Facilitate internal audit program while monitoring processes. • Supervise customer complaint processes, including investigation, corrective action facilitation, and customer response. Responsible for agency reporting as required for defect and adverse event reporting.• Handle recall assessment, facilitation, and activities required to complete effective recall processes, as well as provide all regulatory correspondence associated with regulatory agency notification.• Consistently manage and oversee (CAPA) Corrective and Preventive Action processes for facility(ies).• Provide Quality Control reports that reinforce activities that are being constructed in conformance with quality objectives for sites. Establish standard and constructively confront issues of non-conformances. Show less

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  Owens & Minor

  Mar 2020 - now

  Quality Systems Compliance Manager

  ● Supports the development, deployment, and continuous improvement of an efficient and effective Owens & Minor Global Quality System that supports both the Products and Solutions Strategic Business Units.● Ensures the Owens & Minor Global Quality System is compliant with applicable standards and regulations. ● Ensures the Owens & Minor complaint handling process and Health Authority reporting program is compliant with applicable standards and regulations. ● Manages the corporate quality audit program.● Manages Post Market Surveillance team. ● Manages and leads projects under the global quality project portfolio.● Pro-actively performs data analysis to monitor Quality Systems performance and compliance and where necessary identify opportunities to improve the Owens & Minor Global Quality System. ● Responsible for the centralized maintenance of all documentation and subsequent follow up, tracking and closure of any findings that result from such audits. Show less