Specialist Qa, External Supplier Quality resume example with 16+ years of experience

Jessica Claire
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Biotechnology and Device industry professional with over 16 years of experience. Expert in Quality Management System Implementation and Application, particularly related to Annual Product Review (APR) and Management Review (MR) initiatives. Strong knowledge of global regulations and guidance related to cGMP, Biologics, Medical Devices and Combination Products. Skilled in the implementation of global programs, Product Management / Disposition activities, Six Sigma Methodology, and leading Quality Assurance operations.

  • Accountable leader
  • Results driven
  • Collaboration skills
  • Sound Problem Solving and decision-making skills
  • Analytical skills
  • Project management
  • QMS expertise
  • Laboratory computer systems
  • Quality assurance experience
  • Knowledge of auditing systems
  • Quality Improvement Strategy
  • Corrective Actions
Specialist QA, External Supplier Quality, 10/2018 to Current
Collegium PharmaceuticalStoughton, MA,

Project Leadership

  • Team Lead - Global Deviation Simplification Project, guiding cross-functional team to holistically transform the deviation process across all Amgen sites.

ESQ Leadership

  • Trained Batch Disposition Manager for all phases of drug manufacturing (API / Drug Substance, Drug Product, Final Drug Packaged Drug Product)
  • Partnered with external suppliers, third party auditors and the Amgen team to ensure that audit deliverables were completed in a timely and compliant manner
  • Provided risk management support for supplier related audits
  • Led multiple process improvement initiatives to streamline the audit process from scheduling to closure of audit records
  • Trainer for multiple Amgen quality systems ensuring quality records (Deviation, Change Control, CAPA / Effectiveness Verification and Audit) were closed in a timely manner with high adherence to compliance
  • Trained Major Deviation Investigator

Led Multiple ESQ Management Responsibility Initiatives

  • Led External Supply initiatives for Amgen programs such as Annual Product Review, Management Review and analysis of External Supply Operational metrics
  • Presented / facilitated Monthly External Supply Management Review Meeting and served as a key contributor in terms of data retrieval, analysis and overall project management
  • Provided leadership, integration strategy for new Amgen products (i.e., Otezla), tactical and project management support to ESQ site managers to ensure adherence to achieve operational goals
Business Process Owner, Post Market Surveillance , 03/2017 to 09/2018
Amgen Inc.City, STATE,

Post Market Surveillance Leadership

  • Led the Post Market Surveillance (PMS) program for CE Marked devices at Amgen.
  • Successfully wrote the initial PMS reports for all applicable Amgen products
  • Managed the Post-Market Surveillance Forum to identify potential Medical Device Vigilance events and product improvements
  • Developed / Led and developed initial implementation plan for completion of PMS deliverables
  • Partnered with multiple Amgen functional areas to develop design enhancements

Complaint / Product Security Investigation Lead

  • Owned Product Security Investigations for the Corporate Product Complaints team
  • Developed metrics for Product Complaints Monthly / Quarterly Management Review and Annual Product Review
Specialist QA, Global Quality Assurance, 12/2011 to 03/2017
Amgen Inc.City, STATE,

Annual Product Review (APR) Project Manager

  • Led as project manager for the Annual Product Review Program for sixteen Amgen products
  • Developed Project Plan Implementation strategies to ensure completion of timelines
  • Led Product Teams consisting of more than 100 cross – functional participants throughout the end-to-end APR cycles
  • Designed APR Training strategy / curriculum utilized by cross-functional teams
  • Authored multiple sections of the APRs
  • Subject matter expert for multiple quality systems used in the APR process (deviation, Deviation, Change Control, CAPA / Effectiveness Verification)
  • Successfully developed / executed Operational Excellence initiatives to ensure ease of use for program end users and reduce execution time by roughly 40%, by streamlining Data Extraction, Data Analysis, and identification / elimination of waste and redundancies in the APR process
  • Facilitated the quarterly APR review and product presentation meetings with the Operations Executive Leadership team

Management Review (MR) Support

  • Co-facilitated the quarterly Corporate Management Review meeting with the Operations Executive Leadership team.
  • Developed project plan to support MR timelines
  • Analyzed quality and performance data to support operational decision-making
Senior Associate, Quality Control, 05/2006 to 12/2011
Amgen Inc.City, STATE,

Project Leadership

  • Key contributor in the Amgen Sample Reduction Project, which reevaluated the amount of retain samples collected and resulted in over $1 Million savings in cost avoidance
  • Led multiple simplification projects, leveraging six sigma principles to improve proficiency and reduce costs
  • Led as Project Manager and partnered with Contract Manufacturing/Laboratory sites to coordinate testing schedules for multiple Amgen products, which led to increased testing speed and expedited product release

Reference Standard / Critical Reagent Management

  • Led / Managed the Reference Standard / Critical Reagents program for Amgen Thousand Oaks (ATO) QC by monitoring reagent inventory / availability to ensure supply
  • Partnered with Amgen Analytical Sciences and Stability teams to ensure material expiry date were assessed and qualification initiatives were completed on-time
  • Partnered with ATO manufacturing to ensure that replacement reference standards were produced on-time to ensure business continuity
  • Managed quality records pertaining to reference standards (i.e., Change Control)

QC Support

  • Trained analyst – Environmental Monitoring Lab, Amgen QC Microbiology
  • Subject Matter Expert for Amgen Laboratory Information Management System (LIMS) Templating
  • LIMS lead for ATO Stability Templating program
  • Partnered with Amgen Commercial and Clinical Manufacturing to ensure on-time testing completion in order to meet disposition timelines
  • Served as the primary point of contact for All Incoming Product Complaints for ATO Quality Control. This included ensuring samples were submitted to testing labs, on-time completion of testing, and preparation of All QC Documentation for Regulatory Agencies
Education and Training
MBA: International Business, Expected in 06/2012
California Lutheran University - Thousand Oaks, CA
Bachelor of Science: Biological Sciences, Expected in 06/2000
University of California, Irvine - Irvine, CA


  • Excellence in Quality, Sample Reduction Project, Amgen Inc


  • Recognized as Most Outstanding Humanitarian Award-UCI Flying Samaritans. Presented by the University of California, Irvine, 1998
  • Recognized as Most Outstanding Educational Program-UCI Flying Samaritans. Presented by the University of California, Irvine, 2000
  • Recognized for Excellence in Fundraising-UCI Flying Samaritans. Presented by the University of California, Irvine, 2000
Websites, Portfolios, Profiles

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Resume Overview

School Attended

  • California Lutheran University
  • University of California, Irvine

Job Titles Held:

  • Specialist QA, External Supplier Quality
  • Business Process Owner, Post Market Surveillance
  • Specialist QA, Global Quality Assurance
  • Senior Associate, Quality Control


  • MBA
  • Bachelor of Science

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