Jennette Salgado
Sr. Quality Operations Analyst at Illumina- Claim this Profile
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Tagalog Native or bilingual proficiency
Topline Score
Bio
Credentials
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Writing in Plain Language
LinkedInApr, 2021- Sep, 2024 -
Problem Solving Techniques
LinkedInFeb, 2020- Sep, 2024 -
Critical Thinking
LinkedInJan, 2020- Sep, 2024 -
Green Belt Certification (GB)
Johnson & JohnsonAug, 2007- Sep, 2024
Experience
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Illumina
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Italy
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IT Services and IT Consulting
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1 - 100 Employee
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Sr. Quality Operations Analyst
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Sep 2016 - Present
Responsible for the day-to-day administration of the QA programs in support of the company's Management System. Involved in the development, implementation, and maintenance of Quality System processes to meet the requirements of FDA 21 CFR 820, ISO 13485, and other applicable quality and regulatory standards. Responsibilities includes: • Works with relevant departments to ensure successful implementation of quality systems and processes • Identifies need for CAPA based on analysis of quality date sources and drives to timely completion • Assists process owners and SMEs with risk determination, failure investigation/root cause analysis, action plans, and other improvement efforts to resolve quality issues • Conducts and supports Internal Quality Audits • Supports External Audit activities • Provides guidance to process owners to ensure product and process records are documented in compliance with quality standards, regulations and quality system procedures • Assists in development and delivery of Quality Systems training • Prepares and issues quality metrics, reports, and key performance indicators for management reviews and other forums as required
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Abaxis, Inc.
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United States
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Medical Device
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100 - 200 Employee
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Calibration Chemist Lead
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Feb 2016 - Sep 2016
Responsibilities include:• Assess production start-up for accuracy and acceptable calibration, monitor trends and notifying management of emerging issues• Perform testing, compile the test summaries and conduct statistical analysis• Assist with developing, reviewing, and improving calibration templates and documents; provide input for continuous improvement• Perform routine equipment maintenance and calibration• Provide troubleshooting support and assistance for calibration investigations; provide resource support for qualifications, validations and other requests assigns
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Document Control Supervisor
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Feb 2014 - Feb 2016
Responsibilities include:• Hire, train and supervise Document Control staff • Facilitate approvals of DCO’s• Develop and establish the company’s documentation structure, ensuring appropriate linkages, create and maintain “Where Used” database• Write/facilitate the development of functional Quality System documents• Effectively support and participate in internal, customer, and third party audits• Manage the company Training Program to ensure training requirements for all employees have been adequately assessed and are in current status• Manage/coordinate translations of company literature with an external translation company• Control and manage laboratory notebook and equipment log books issuance and filing• Participate in Quality System improvement initiatives as assigned
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Quality Assurance Specialist
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Sep 2013 - Feb 2014
Responsibilities included:• Performing Internal Audits• Developing CAPA plans and executing action items • Updating Quality System metrics • Compiling data for Management Review slide presentations• Maintaining Supplier Files and Training Matrix• Tracking Management Review action items and Quality Objectives to closure
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QC Rotor Technician Assistant Lead
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Oct 2011 - Sep 2013
Responsibilities included:• Performing QC functions such as inspection, testing, and auditing• Collecting test data and generating reports• Initiating Nonconformance Reports• Participating in the reduction of nonconformances• Performing preventive maintenance on QC test analyzers• Performing Lead functions in her absence• Assisting Lead on schedules, document changes, and special projects
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LifeScan
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Medical Equipment Manufacturing
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700 & Above Employee
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Laboratory Assistant
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Jan 2011 - Oct 2011
*Preparation of equipment and materials for test protocols * System verification and validation testing * Test Method Development * Data Entry and Analysis *Preparation of equipment and materials for test protocols * System verification and validation testing * Test Method Development * Data Entry and Analysis
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Lifescan Inc
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United States
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Hospitals and Health Care
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Process Technician IV
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Oct 1997 - Dec 2009
Lead (promoted four times from Technician I) Responsibilities include: * Planning and scheduling the day to day activities of Technicians based on monthly goals * Resolve product issues regarding equipment, processes, materials and procedures by working with Quality Assurance, Engineering, and Maintenance Department * Function as technical expert on products and processes * Provide input to management regarding Technician issues, capacity constraints, equipment and calibration issues * Represent manufacturing on teams and special project * Recommend and participate with process improvement and changes * Participate in the reduction and elimination of Non-Conforming Reports (i.e. investigating, writing reports retraining technicians and/or changing procedures) * Performs line technician's task to ensure all stations has an assigned technician. * Ensure pass down between shifts and areas are completed effectively
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WesCorp
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Ecuador
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Retail Groceries
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1 - 100 Employee
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Data Entry Technician
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Jun 1985 - Jul 1997
Reconciling Accounts Processing Checks from other Credit Union Reconciling Accounts Processing Checks from other Credit Union
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Education
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2010 - 2011
Heald College Hayward
Certificate, Accounting -
1989 - 1994
California State University-East Bay
BS, Health Science; an option in Human Biology
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