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Abel Salgado is listed as Quality Specialist II @ Thermo Fisher | MDR, IVDR, Documentation Control at Thermo Fisher Scientific, a company with 53105 employees, based in Chula Vista, California, United States. AeroLeads shows a matched LinkedIn profile for Abel Salgado.
Abel Salgado previously worked as Quality Specialist II at Thermo Fisher Scientific and Regulatory Affairs Specialist at Acon Labs Incorporated. Abel Salgado holds Master Of Business Administration - Mba, Business, Management, Marketing, And Related Support Services from Point Loma Nazarene University.
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With over a decade of dedicated experience in Quality Assurance and Regulatory Affairs (QA/RA), I bring a wealth of expertise to the table, particularly specializing in Quality Management System (QMS) auditing. In my role as a Quality Specialist II at Thermo Fisher Scientific, I've continually refined my skills in document control and regulatory compliance, emphasizing my proficiency in conducting thorough and effective quality audits.Throughout my career, I've demonstrated a proactive approach to auditing that has proven pivotal in optimizing operations and ensuring strict adherence to FDA and ISO standards. My commitment to excellence and meticulous attention to detail have consistently contributed to the enhancement of organizational efficiency and regulatory compliance.I am passionate about leveraging my extensive experience and knowledge to drive continuous improvement and uphold the highest standards of quality within the industry.
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Carlsbad, California, United States
Manage document control functions related to the Quality Management SystemSupport Quality Management System activities, including document submission for release in Agile PLM, TrackWise, and SAPConduct internal QMS audits for Cross-functional teamsAssist in completing Customer Supplier Audit QuestionnairesReview and contribute to Supplier Quality.
Mira Mesa, California
- Managed all aspects of regulatory submissions relevant to assigned projects.- Technical Writer/Reviewer, CTD/BLA Filing, Risk Assessments, Protocol & Report Writing- Authored the change control protocols for medical device manufacturing. - Lead the development of briefing documents for formal regulatory meetings.- Initiated and contributed to process.
Sorrento Valley, California
- Established operational SOPs and procedures.- Reviewed and approved Master and executed Batch Records for Drug Substance and Drug Products, stability protocols and reports, and specifications. Including communication of findings to vendors responsible for the listed records and ensuring corrected documentation is received.- Reviewed all documentation for.
Sorrento Valley, California
- Maintained the Document Control system by issuing document numbers, processing change controls, and releasing, scanning, and filing documents manually and then in the electronic Document System.- Generated procedures and forms as necessary to support the Quality Management system.- Reviewed and approved Master batch records, labeling of material, and lot.
Scripps Ranch, California
-Oversaw the development, management, and maintenance of lot release and final QA review processes.-Monitored documentation to ensure timely and efficient resolution and completion of issues, non-conformances, projects, and deviations.-Streamlined batch record review cycle times by establishing quality metrics to track performance and pinpoint areas for.
Mira Mesa, California
Administered the NC/CAPA files and actions, and assist process owners with completing NCs, CAPA actions, and associated tasks.Supported the Corrective Action Review Board and users with the CAPA process, record content, and software usage.Contributed to the development, implementation, and ongoing improvement of Quality System NC/CAPA procedures, software.
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Kevin Fairfax
Colleague at Thermo Fisher Scientific
Redhill, England, United Kingdom, United Kingdom
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Indra Reddy
Colleague at Thermo Fisher Scientific
Hyderabad, Telangana, India, India
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Danielle Camilleri
Colleague at Thermo Fisher Scientific
Hoppers Crossing, Victoria, Australia, Australia
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Arturo Osorio
Colleague at Thermo Fisher Scientific
Mexico City, Mexico, Mexico
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Sophia Angela Bosnjak
Colleague at Thermo Fisher Scientific
Hungary, Hungary
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Miriam Troiano
Colleague at Thermo Fisher Scientific
Monte Sant'Angelo, Apulia, Italy, Italy
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Reham Mahmoud
Colleague at Thermo Fisher Scientific
Greater Boston, United States
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Divya Kotha
Colleague at Thermo Fisher Scientific
Pittsburgh, Pennsylvania, United States, United States
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Oscar Ustariz
Colleague at Thermo Fisher Scientific
Madrid, Community Of Madrid, Spain, Spain
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Isabel D. Colón Bernal, Ph.D.
Colleague at Thermo Fisher Scientific
Allison Park, Pennsylvania, United States, United States
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Coursework in managerial accounting, marketing research, financial management, operations management, strategic management, legal, ethical.
Quick answers generated from the profile data available on this page.
Abel Salgado works for Thermo Fisher Scientific.
Abel Salgado is listed as Quality Specialist II @ Thermo Fisher | MDR, IVDR, Documentation Control at Thermo Fisher Scientific.
Abel Salgado is based in Chula Vista, California, United States while working with Thermo Fisher Scientific.
Abel Salgado has worked for Thermo Fisher Scientific, Acon Labs Incorporated, Ajinomoto Bio-Pharma Services, Vical, and Werfen.
Abel Salgado's colleagues at Thermo Fisher Scientific include Kevin Fairfax, Indra Reddy, Danielle Camilleri, Arturo Osorio, and Sophia Angela Bosnjak.
You can use AeroLeads to view verified contact signals for Abel Salgado at Thermo Fisher Scientific, including work email, phone, and LinkedIn data when available.
Abel Salgado holds Master Of Business Administration - Mba, Business, Management, Marketing, And Related Support Services from Point Loma Nazarene University.
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