supplier quality specialist resume example with 20+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000,
Professional Summary

Quality Professional, with 6 years of experience in Quality assurance and Regulatory Control and an ASQ Certified Quality Auditor with a background in Medical Device and Pharmaceutical manufacturing. A demonstrated ability to work independently, or cross functionally and within many area of Quality. In addition to Quality I also have 2 years in Nurse call helpdesk support and over 10 years of IT and customer service support. My previous experience will show I am task oriented ,results driven, hard working and loyal . I am always looking to learn more.


ASQ Certified Quality Auditor- Expires 12/31/2017

Core Competencies
  • Post Market Complaint Surveillance
  • Supplier Compliance for Medical Devices and Pharmaceutical Manufacturing.
  • Metric Reporting
  • Internal and External Auditing Management.
  • CAPA
  • Process Improvement
  • Process Training
  • Medical Devices (GMP, Code of Federal Regulations part 820
  • GMP Training
  • MDR Response
  • Root Cause analysis
  • Risk Assessment
  • Non-Conforming material Disposition
  • Supplier Relations
Professional Experience
10/2014 to Current Supplier Quality Specialist Catalent Pharma Solutions, Inc. | Greendale, IN,
  • Assessed suppliers capability of meeting manufacturing standards and various regulatory standards including ISO, FDA, cGMP.
  • Maintained approved supplier List and supporting new supplier qualifications. Input all Trackwise change requests.
  • Performed Supplier Risk assessments
  • Reviewed Supplier Agreements, and specification forms
  • Reviewed Customer change notifications for impact to agreement and specifications.
  • Worked with site resources in Incoming Quality, Materials management and Site management to perform activities required to resolve supplier site quality issues.
  • Participate in audits of suppliers against appropriate global and regulatory requirements and provide written reports to auditees and management while following up on corrective actions.
  • Compile and assess APQR data, management review metrics, supplier status, and procedure compliance.
  • Develop and review quality/technical agreements, vendor specification criteria and work with site management to resolve vendor exceptions.
  • Prepare vendor noncompliance notifications as needed.
  • Provide support for product investigations involving incoming commodities.
  • Participated in the assessment of suppliers through supplier audit program.
  • Participated in the Global Supplier Compliance meetings to ensure compliance at the site level.
  • Assisted owners in driving all Supplier related CAPAs to closure
  • Provided supplier scorecard metrics to Global support on a monthly basis.
07/2009 to 08/2014 QARA Specialist Isys Technologies | Ogden, UT,
  • Reviewed and processed customer complaints for all products within the complaint system and ensured compliance to governing regulations and processes.
  • Worked with Technical Support, Field support and Engineering to ensure complaint investigation details were appropriately documented.
  • Performed initial review and generated weekly report of complaints found to be potentially reportable events per Medical Device regulations.
  • Monitored complaint metrics weekly to ensure timely completion.
  • I generated and distributed monthly and quarterly trend reports to management on the backlog state.
  • Held weekly meetings to monitor non-conforming material for trends.
  • Managed supplier compliance activities: evaluation and certification of new suppliers, monitored supplier performance on a monthly basis and performed bi-annual meeting with Supply Chain manager and Field service manager, performed maintenance updates to supplier information as needed, performed auditing and corrective action activities for all suppliers.
  • Served on global supplier quality council to provide monthly health check to corporate of all open and new supplier issues.
  • Managed CAPAs providing leadership activities, monitored progress of corrective actions, and tracked activities to completion.
  • Trained all PQRs and Complaint Analysts on complaint handling processes on ongoing basis.
  • Participated in internal and external audits and responded to FDA warning letters.
  • Managed process improvement projects from beginning to closure.
05/2007 to 06/2009 Product Quality Representative Analogic Corp | Peabody, MA,
  • Provided level I and II technical support for Nurse Call products troubleshooting them to resolution or escalating as necessary to R&D or dispatching field service for onsite support.
  • Monitored customer emails for reported product issues and performed callbacks.
  • Performed proactive monitoring of system alerts and performed callbacks to sites to validate alerts and correct issues.
  • Assisted field technicians with application troubleshooting, remote access testing and parts ordering.
  • Served as group lead trained all new PQRs to onboarding checklist activities.
12/2006 to 05/2007 NOC Support Analyst Kroger | Durango, CO,
  • Responsible for initial troubleshooting and problem solving.
  • Responsible for ticket creation, resolution/delegation, and escalation of all customer issues.
  • Fielded all incoming technical calls, emails, and alerts.
  • Created all initial trouble tickets, Routed or escalated calls to level II as appropriate, Monitored Netcool for incoming alerts, validated these alerts.
  • Performed all initial troubleshooting, reviewed VERITAS NetBackup activity monitor for past failures, reran failed backups, Upped down drives via VERITAS NetBackup.
  • Provisioning, validated all provisioning requests performed, service starts, suspends, resumes, service changes, and stops, backup on demands, tapes on demand, and beginning to learn how to perform restores on demand.
  • Maintenance management, tracked all maintenance details, provided partners with updates, changes and resolution details.
04/2005 to 05/2007 Technical Support Technician Verizon Business | City, STATE,
  • Provided Level I support monitored and troubleshot server and network issues in a 24x7 network operations center.
  • Served as the liaison between customer and local telephone companies for all phone, internet, PIP, ATM, Private line, VoIP, and frame circuits.
  • I coordinated dispatch as necessary.
02/1999 to 08/2004 Helpdesk Coordinator Sr. District Helpdesk/Postalone Coordinator EDS | City, STATE,
  • Responsible for troubleshooting all Hardware, Software, and Network connectivity issues for Windows 95,98,2000 and XP workstations.
  • Performed Security Administrator functions for all 95-2000 and XP workstations.
  • Performing Security Administrator functions for Outlook Client, and Outlook Webaccess, Troubleshooting in both the Novell and ACE environment.
  • Daily tracking of personal tickets to ensure timely closure, Training individuals on Postalone, SME mentor.
03/2001 to 10/2001 Backup Supervisor EDS | City, STATE,
  • Supervision of a desk of 15 analysts daily (Econnectivity).
  • Review of ACD and MTE data to ensure adherence to team responsibility.
  • Provide feedback to analysts on performance issues.
  • Provide mentoring and training, coordinate and complete skill assessments, facilitated team meetings.
  • Completed monthly reports of desk status to give to Supervisor.
  • Developed and communicated rotation of scheduling.
  • Ensured prompt ticket resolution.
  • Reviewed and assisted with call volume.
  • Coordinated team moral, welfare, and recreation.
01/2001 to 03/2001 Operations Hiring Backup EDS | City, STATE,
  • Responsible for facilitating and conducting first level interviews for possible EDS candidates.
  • Assisted Operations backup with leveraging duties, and forecasting analyst coverage for entire level one support.
01/1999 to 2001 Desktop Applications Support EDS | City, STATE,
  • Performed maintenance on IBM and.
  • NCR POS equipment performed resets, calibrations, id resets and troubleshoot hardware or software.
  • Supported Dinero Seguro, a money wire system used by USPS customers to send.
  • money to Mexico, and Delivery Confirmation a new system used by USPS for mail tracking.
Education and Training
Expected in May, 1999 to to Bachelor of Arts | Criminal Justice/Pre-Law Shaw University, Raleigh, North Carolina GPA:

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Computer Skills

Trackwise, Agile, CRM Client, Lotus Notes, Microsoft Office, Outlook, Power Point, PC Anywhere, Powerpoint Presentations, SAP (Document Mgmt System), WebEx, Windows XP-8, JDE, FTP, EZ Track, PC Anywhere, HRRS, Clear Quest, Jama/Jira, Remedy, Sametime.

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Resume Overview

School Attended

  • Shaw University

Job Titles Held:

  • Supplier Quality Specialist
  • QARA Specialist
  • Product Quality Representative
  • NOC Support Analyst
  • Technical Support Technician
  • Helpdesk Coordinator Sr. District Helpdesk/Postalone Coordinator
  • Backup Supervisor
  • Operations Hiring Backup
  • Desktop Applications Support


  • Bachelor of Arts
  • Select One

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