Quality Professional
Resume:
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teresa
robertson
professional summary
Dedicated professional with demonstrated strengths in customer service, time management and trend tracking. Good at troubleshooting problems and building successful solutions. Excellent verbal and written communicator with strong background cultivating positive relationships and exceeding goals.
experience
Edwards Lifesciences Irvine, CA
May 2019 - Current
Senior Supplier Quality Engineer
• Oversaw the selection, assessment, and qualification of suppliers including supplier audits to ensure that products received from external suppliers conform to pre-established requirements
• Lead Supplier Audits as a Lead Auditor; trained colleagues to be Lead Auditors
• Headed investigations into part dimensional issues, specifically for the T-rail part, to include providing a fixture design solution and new measurement method (routine) to support the transfer of the part for Receiving at a sister site.
• Developed and implemented Fit for Purpose - NPD RI Optimization Measurement Process improvement to include an equipment catalog.
• Managed validation methods of critical suppliers and incoming quality control aligned with international standards, global regulations, and industry best practices
• Drove optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement
Azzur Group Irvine, CA
January 2016 - May 2019
Consultant, Quality Engineer
• Managed/authored completion of over 100+ quality investigations to include containment and assessment of risk to product/process by interfacing with every Department at the client site. Investigations included understanding of various equipment, such as, lyophilizers, autoclaves, depyrogenation tunnels, vial washers and calibration standards (cycle parameters not met, out of tolerance results at calibration, etc.), environmental excursions
(critical utilities, differential pressures, chambers, non-viable particulate and bioburden limits exceeded), incoming quality assurance discrepancies, documentation issues, etc. Completed Root cause analysis using 6M and other quality tools. Communicated investigation results. Developed CAPA plans.
• Developed protocols, and TMV Reports for automated vision inspection system, Keyence Vision System, of 70 plus parts; Authored rationale document to support project path forward decisions for dealing with changes to Engineering drawings post validation.
• Remedied gaps in firm's current documents and processes through the analysis and publication of a comprehensive Master Validation Plan Gap assessment. Allergan (Formerly Activis/Watson) Corona, CA
Corona, CA 92882
W: *****************@*****.***
skills
• CAPAs (Corrective
Action/Preventive Action)
• Investigations/Root Cause Analysis
(NCRs/SCARs)
• Auditing
• Engineering Change Management
• Quality Management
Systems/AS9100 Compliance
• Failure Modes and Effects Analysis
• Statistical analysis proficiency
• Six Sigma Methodologies
• Process Validation
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January 2003 - January 2016
Quality Assurance Engineer, Principal
• Headed Customer Complaints, Retains Area and Internal Auditing
• Drove completion of Customer Complaints for Post Market Surveillance with strick adherence to time limits; trended Customer Complaints, authored Closure Letters/Sample Request Letters, communicated with Reporters/Complainants to Retrieve Return Samples and follow up
Allergan (Formerly Activis/Watson) Corona, CA
January 2003 - January 2014
Senior QE Specialist/Quality Assurance Engineer
• Compiled and maintained historical profiles for products manufactured at the Corona site while keeping within tight deadlines Reviewed, analyzed, and submitted data, to include statistical control charts for product data, related to the submission of Annual Product Reviews (APRs). Summarized, reviewed and completed analysis of the product data into technical documents to include recommendations
• Reviewed Temperature/Humidity Warehouse charts against Standard Operating Procedure specifications.
Amphastar Pharmaceuticals Rancho Cucamonga, CA
December 1999 - January 2003
Process Validations Supervisor/Validations Technician/Validation Engineer
• Supervised and trained four (4) Validation Technicians/Engineers
• Oversaw user roles and passwords, trouble shot as the Computer System Administrator for the GE Kaye Validator 2000 System
• Performed and coordinated studies in areas relating to drug manufacturing processes to include media fills, closure integrity, cleaning and process validations.
• Supported launch of three new products via completion of the process validation sections of NDAs/ANDAs to support Regulatory submissions.
• Authored protocols executed Dry Heat Oven, Depyrogenation Tunnel, Autoclave, and other equipment qualifications. Executed Warehouse temperature mapping, executed Refrigerator and Freezer equipment qualifications, wrote Final Reports. education
Bachelor of Science, Biology
California State Polytechnic University, Pomona
Certificate of Pharmaceutical Engineering
California State University, Fullerton
System skills
• J.D. Edwards (inventory management system)
• SAP (inventory management system)
• Labware LIMs for EQL (laboratory information management system)
• Empower (laboratory software for chromatography)
• TrackWise (compliance database)
• MasterControl (Electronic Document management)
• Ignite (Electronic Document management)
• GE Kaye Validator (temperature mapping)
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• Maximo (database used for Equipment PM and calibration tracking)
• Keyence Vision Systems (vision system for dimension measurement)
• JDOC Certified (Edwards format standard procedure mastery)
• JMP (statistical software)
• Minitab (statistical software)
certifications
Certified Quality Auditor, American Society of Quality, 2010 language
Spanish - Conversational
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