Quality Assurance Document Review

Rosa Nungaray

San Diego, CA rosa.nungaray.**@gmailcom 714-***-****

Professional Summary

Highly dedicated and disciplined Manufacturing Review Group Lead with 15+ years of

Manufacturing and GXP Operations experience. Possesses exceptional attention to detail and a proven track record in Batch Record Review, Visual Inspection, and

Aseptic Operations within Classified Cleanrooms. Skilled in evaluating human nature and operational error tendencies, while maintaining GXP records in compliance with industry standards. Adept at problem-solving, with a focus on quality assurance and process improvement.

Work Experience

.

Quality Engineer

AJINOMOTO BIO-PHARMA SERVICES-San Diego, CA

January 2024 to September 2024

Collected and analyzed KPIs from executed batch records for Validation Protocols.

Developed custom templates for data extraction from Batch Records.

Manufacturing Quality Document Review/Document Review Team Lead

AJINOMOTO BIO-PHARMA SERVICES-San Diego, CA

April 2012 to January 2024

Biologics and Drug Product Manufacturing Departments

* Led Biologics and Drug Product Manufacturing Department Document Review Team (3 personnel).

* Execute SOP's. bath records and other cGMP documentation.

* Adhere to quality standards set by regulations and accordance to

* Ensured the timely review of production batch records and associated data for product release and determined conformance of records to cGMP standards.

* Conducted materials reconciliation of Materials Management System to ensure 100% traceability of raw materials.

* Served as the principal point-of-contact and representative of Drug Product Department to interdepartmental Quality teams.

* Reviewed Buffer Batch Records and associated data for product release and determined if records were consistent with internal and external guidelines.

* Conceived, refined and implemented Batch Record Review qualification program incorporating the use of comprehensive mock documents with an empirical grading scheme.

* Instituted detailed metrics tracking and monitoring human errors in Batch Record execution. Enhanced awareness of mistakes resulted in a 22% reduction in document errors year over year.

* Familiar with equipment in a sterile drug manufacturing, including but not limited depyrogenation ovens, autoclave and aseptic techniques and cleanroom behavioral concepts.

Visual Inspection Technician / Manufacturing Associate

AJINOMOTO BIO-PHARMA SERVICES-San Diego, CA

Drug Product Manufacturing

June 2009 to April 2012

Effortlessly applied attention-to-detail for inspection activities and assumed responsibility for various manufacturing tasks under the guidelines of established SOP and cGMP regulations, wielding strong problem-solving abilities to assure consumer satisfaction.

* Ensured consistent communication with Leads and Operations Associates.

* Performed Aseptic manufacturing / Fill Finish operations within classified cleanrooms such as Glass Wash, Vial Wash prep for sterile fills. Conducted equipment troubleshooting as required.

* Applied extremely acute attention-to-detail to the Visual Inspection operations for product-filled vials.

* Electronic labeling of vials

* Prepared client requested samples and maintained AQL and associated documentation for final product shipment.

* Adopted and reinforced rigorous Good Manufacturing Practice (GMP) standards when recording data and completing Batch Records.

* Performed other manufacturing duties as assigned.

Quality Assurance and Manufacturing Technician / Material Handler

ILLLUMINA-La Jolla, CA

January 2008 to December 2009

* Biochemical's/Chemical/Reagent handling removing them from freezer conducting visual inspection and preparing them for Kit assembly. Labeling and packaging utilizing vacuum sealers and zebra printers following order requests. Performing data entry for tracking with LIMS (Laboratory Information Management System)

* Prepared and staged materials when utilizing automated manufacturing equipment. Operated Watson array machines, loaded and unload arrays for Matrices Decodes following recipe.

* Performed inventory and work order transactions with JDE enterprise software system using Barcoding / Barcoding Scanning to maintain accurate inventory records.

Assembly Technician

CALIFORNIA ANALYTICAL INSTRUMENTS-Orange, CA

January 2007 to December 2007

Assembled gas analyzers following blueprints, including wiring, soldering, plumbing, and equipment testing for proper functionality.

Technician

STATEK-Orange, CA

January 2006 to December 2007d

· Operated machinery to test manufactured quartz crystals, oscillators and sensors used in aerospace & defense, Medical instruments & implantable. Testing for oven temperature readings for highly stable frequencies at increasing higher operating temperatures. Visual inspection and packaging on final product meeting shipment timelines.

Shift Lead/Backup Supervisor

FLUIDMASTER, INC-San Juan Capistrano, CA

January 1994 to December 2001

· Supervised 35+ employees, managed work schedules, and conducted performance reviews.

· Ensured quality assurance testing and on-time shipping of final products.

Skills

•Team Leadership

•GXP Operations

•Batch Record Review

•Quality Assurance

•SOP Development

•Inventory Management

•Technical Assembly

•Aseptic Manufacturing

•Process Improvements

•Data Collection and Analysis

•Labeling

•Packaging

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