Summary
Overview
Work History
Education
Skills
Timeline
Generic
Adriana Cordova

Adriana Cordova

Quality Assurance
Piscataway,NJ

Summary

Results-driven professional with expertise in training, Quality Assurance, and Production Leadership. Skills include developing and delivering engaging training programs, implementing standardized operating procedures, ensuring regulatory compliance (following GMP guidelines and regulations), and utilizing technology for enhanced communication and organizational success. Demonstrated ability to lead teams, streamline processes, and achieve production targets while maintaining the highest quality standards. As a Document Control Specialist, experienced in storing, managing, and maintaining critical company and project documents in accordance with ALCOA and cGMP guidelines, ensuring accuracy and quality. Proficient in processing documents for revision and approval, organizing them from conception to distribution and filing, and creating systems to train staff on document control processes. A growth mindset drives commitment to help the team move the business forward with any task.

Overview

23
23
years of professional experience
1
1
Language

Work History

Document Control Specialist

Amneal Pharmaceutical
Piscataway, NJ
02.2024 - Current

Worked with internal staff to process documents.

  • Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
  • Collaborated across departments and levels of management to gain consensus on procedural documentation.
  • Provided assistance with inbound and outbound document requested over 100 requested per day, document sorting, logging, and work order creation.
  • Providing additional pages for Batch Records.
  • Preparing Logbooks for different purpose.
  • Providing Batch Record for Internal Review
  • Collecting CofA in Master Excel
  • Archiving Protocol

Quality Assurance Specialist I

Halozyme
Ewing, NJ
01.2022 - 06.2023
  • Quality processes were supported , including manufacturing, by reviewing Master Batch Records for three mayor products and ensuring conformance for each batch of auto-injectors. Additionally, monitoring manufacturing dates , expiration dates , and Stability time points were collected according to company specifications. Furthermore, overseas shipment temperature conditions were reviewed .
  • Managed quality processes for Product Quality Complaints, Deviations, and Change Controls from Contract Manufacturing Organizations (CMOs) . When nonconformances or deviations arose during manufacturing, they were carefully recorded in company's system.
  • Facilitated data collection for periodic performance metrics by collecting data for each lot of manufactured auto-injectors. This process involved tracking process start dates , overseas shipment dates , packaging arrival at CMO , and final third-party destinations before releasing auto-injectors to market.
  • Collaborating with cross-functional teams , Streamlined processes to enhance efficiency in pharmaceutical manufacturing and product development.

Production Trainer

Demant Inc.
Somerset, NJ
12.2001 - 12.2021
  • In Quality Control , final products were assessed , and digital equipment was serviced using computer software. Additionally, Quality Control Department received assistance in process of validations to ensure equipment was validated to latest version.
  • Collaborated closely with supervisor on task and quality issues, while maintaining strong relationship with Production Management to increased productivity levels with efficient scheduling practices that maximized resource utilization on production floor.
  • Regular assessments of employee performance were conducted, identifying areas for improvement and providing targeted coaching. Additionally, production efficiency was improved through implementation of streamlined training methods and procedures.
  • New employees were trained in various processes related to manufacturing of hearing devices, including BTE and ITE. These tasks involved trimming ear molds and mounts , soldering , and troubleshooting for quality fit and usage . Training was conducted globally, and blueprints were utilized to solder electronic devices using an microscope.
  • In Quality Control , final products were assessed , and digital equipment was serviced using computer software. Additionally, Quality Control Department received assistance in process of validations to ensure equipment was validated to latest version.
  • Managed the Change Notification process for the Training Department, ensuring accurate and up-to-date documentation. Facilitated seamless information flow and updated each production department with the latest applicable implementation, ensuring that all teams understood the updated instructions.
  • Document Management and Record-Keeping : Extensive experience in document management and record-keeping.
    Skilled in capturing paper-based records for tracking employee training. Utilized advanced Excel skills to create, scan, and link training documents.

Operations Matrix Maintenance Consistently updated, added, and removed documents in the Operations Matrix. Ensured accurate and relevant information for training purposes.

  • MDSAP Audit Preparation : Played crucial role in preparing company for MDSAP by meticulously maintaining Operations Matrix. Consistently updated, added, and obsolete, ensuring accurate and relevant information for training purposes. As result, we created comprehensive and easily accessible training database, significantly reducing time spent searching for documents during company audits. Additionally, ensured timely distribution of training records when needed.
  • As Global Trainer supporting affiliated companies across different countries, demonstrated dedication by traveling to deliver on-site training during transfer processes. This facilitated smooth knowledge transfer and minimized disruptions. Also collaborated closely with colleagues to build new dedicated team, resulting in successful DGS training and improved overall performance. Additionally, provided multi-country training support through Microsoft Teams in Spanish, effectively facilitating communication and knowledge sharing within Global Training Organization.
  • Used Master Control to design training for new and existent employees and increase company retention and productivity rates 50%
  • Trained and mentored new personnel hired to fulfill various roles

Education

Some College (No Degree) -

Raritan Valley Community College
Somerville, NJ
05.2001 -

High School Diploma -

Plainfield High School
Plainfield, NJ
06.2024 -

Skills

Timeline

High School Diploma -

Plainfield High School
06.2024 -

Document Control Specialist

Amneal Pharmaceutical
02.2024 - Current

Quality Assurance Specialist I

Halozyme
01.2022 - 06.2023

Production Trainer

Demant Inc.
12.2001 - 12.2021

Some College (No Degree) -

Raritan Valley Community College
05.2001 -
Adriana CordovaQuality Assurance