Specialist Qa, External Supplier Quality resume example with 16+ years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 Montgomery St. 10th Floor
Home: (555) 432-1000
Cell:
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Summary
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.
Skills
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
Experience
Specialist QA, External Supplier Quality, 10/2018 to Current Collegium Pharmaceutical – Stoughton, 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)
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 GPA:
Bachelor of Science: Biological Sciences, Expected in 06/2000 University of California, Irvine - Irvine, CA GPA:
Accomplishments
Professional
Excellence in Quality, Sample Reduction Project, Amgen Inc
Humanitarian
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
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