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supplier quality specialist resume example with 20+ years of experience

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Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
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.

Certifications

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:

Expected in to to Select One | , , GPA:

AAMI- QUALITY SYSTEM REQUIREMENTS TRAINING

Expected in to to | , , GPA:

CfPIE- MEDICAL DEVICE EFFECTIVE POST MARKET SURVEILLANCE TRAINING

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

Degrees

  • Bachelor of Arts
  • Select One

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