Abel Salgado Email & Phone Number

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 AgreementsMaintain multiple teams' documentation used in the quality management systemCollaborate with team subject matter experts to develop Process Flows, SOPs, Work Instructions, and training materialsInvestigate customer complaints pertaining to services provided by GSSOversee the GSS CAPA SystemReport on quality metricsDeliver training on QMS SOPs and other quality-related topics to GSS teamsProject: Data-Driven Quality Improvement InitiativeObjective: Enhance Quality processes and reduce non-compliance incidents.Tools Used: PowerBI, Oracle Cloud Reporting.Tasks:Collected and integrated data from multiple sources into Oracle Cloud .Created interactive dashboards in PowerBI to visualize quality metrics and trends.Conducted in-depth data analysis to identify root causes of quality issues.Presented findings to the quality management team, providing actionable insights for process improvements.Monitored the impact of implemented changes through ongoing data tracking and reporting.

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 improvements that impact R&D and marketing.- Managed activities to maintain regulatory filings and provided regulatory guidance to cross-functional teams.

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 the release of API and drug products for use in clinical and nonclinical studies.- Coordinated the review, approval, issue, and maintenance of QA-controlled documents and records including SOPs, Templates, and Technical Reports.- Reviewed and approved deviation investigations, CAPAs, and change controls.- Performed internal and supplier qualification audits.- Supported regulatory inspections and inspection readiness activities.- Assisted in ensuring the company maintains its compliance with GLP and GMP where required.

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 release for product.- Responsible for the Compliance program including assigning and approving Deviations, and Nonconformance reports under supervision.- Updated Quality logs for tracking and trending compliance metrics using excel dashboards.- Approving Equipment IQ/OQ/PQ protocols & reports, equipment use logs, calibration logs, maintenance logs, and maintaining equipment files.- Performing Quality metrics, and identifying trends for QA metrics.- Supported Quality audits for the internal audit program, external audits (suppliers), or 3rd party audits by investigators.- Performed manufacturing line clearances, and clean room monitoring activities, and reviewed environmental monitoring reports for compliance.

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 enhancement.-Evaluated GMP documents in accordance with change control procedures.-Approved vendor proofs, including package inserts, labels, and operator manuals, by comparing them to master artwork for distribution.-Analyzed and reported Key Quality Indicator data, identifying trends and spearheading Continuous Quality Improvement efforts.

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, and training.Offered guidance to NC owners in preparing appropriate non-conformance documentation.Assisted CAPA owners in utilizing Quality tools for root cause analysis.Conducted historical searches to aid risk assessments, NC/CAPA investigations, and validations.Applied critical reasoning skills to participate in, carry out, and assess investigations into quality issues.Utilized program management abilities to guarantee the establishment of proper controls and corrective actions, preventing nonconformance recurrence. Develop and implement statistical methods for verifying CAPA effectiveness.Engaged in and support the effectiveness evaluation of CAPA.Monitored NC/CAPA process metrics to facilitate improvement activities and management review.Ensured the completeness of NC/CAPA records, including accurate connections and references to other Quality processes.Helped manage the archiving and handling of scanned CAPA records.

Master Of Business Administration - Mba, Business, Management, Marketing, And Related Support Services

Coursework in managerial accounting, marketing research, financial management, operations management, strategic management, legal, ethical.

Bachelor Of Science - Bs, Biochemistry And Molecular Biology