Summary
Overview
Work History
Education
Skills
Timeline
Generic

Astride Noncent

Irvington,NJ

Summary

Experienced with managing and organizing comprehensive documentation systems. Utilizes advanced software tools to ensure accuracy and consistency in all documents. Skilled in collaborative techniques to support team efficiency and project success. Proficient in Adobe Acrobat and SAP integration, with a proven ability to streamline processes and maintain regulatory compliance.

Overview

5
5
years of professional experience

Work History

Document Specialist II

Stepan
02.2024 - 11.2024
  • Scheduled and coordinated meetings and performance reviews.
  • Addressed employee and customer concerns while fostering workplace efficiency.
  • Supported learning and development of team members and cultivated an inclusive environment.
  • Prepared digital files, physical documents and work requests in compliance with company guidelines.
  • Conducted OSHA audits and resolved POS system issues.
  • Managed high volumes of documents efficiently, prioritizing tasks according to deadlines and project requirements.
  • Performed regular audits of document repositories, ensuring the accuracy and integrity of all stored information.
  • Reviewed and compiled regulatory documents for FDA and international submissions, including booklet submissions for regulatory approval.
  • Developed training materials, participated in SOP writing, and created protocols aligned with 21 CFR Part 820, ISO 13485, and EU IVDR standards.

Quality Assurance Specialist

American Spraytech
03.2023 - 01.2024
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
  • Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
  • Optimized workflow efficiency by introducing automation tools into the QA process where appropriate.
  • Oversaw the creation and maintenance of batch records, ensuring adherence to regulatory standards.
  • Integrated MES with SAP, optimizing data flow and operational efficiency.
  • Conducted internal audits, root cause analyses, and corrective actions for quality issues.
  • Collaborated on FDA approval strategies and prepared technical documentation for regulatory submissions.

MES Design Assistant /Senior Quality Assurance Specialist

Ashland Chemical
02.2021 - 02.2023
  • Assisted with the creation of visually appealing presentations to effectively communicate design concepts and ideas.
  • Enhanced design project efficiency by streamlining communication between team members and clients.
  • Provided valuable input during brainstorming sessions, contributing to the development of creative design solutions.
  • Ordered samples from vendors to handle presentation creation activities.
  • Implemented MES PAS-X systems, enhancing aseptic manufacturing processes.
  • Collaborated with cross-functional teams to ensure streamlined operations and compliance.
  • Conducted supplier evaluations and internal audits, identifying and addressing non-conformances.
  • Maintained detailed documentation, including SOPs, batch records, and regulatory filings.

Quality Control Inspector

Roche Pharmaceuticals
07.2020 - 02.2021
  • Communicated with production team members about quality issues.
  • Inspected quality of products, taking note of functionality, appearance and other specifications.
  • Inspected incoming and outgoing materials for accuracy and quality.
  • Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
  • Performed visual inspections and non-destructive tests where appropriate.
  • Improved product quality by conducting thorough inspections and identifying defects in a timely manner.
  • Maintained compliance with industry regulations through meticulous record-keeping and documentation of inspection results.
  • Collaborated with production staff to establish and meet quality standards
  • Completed precise measurements using special tools.
  • Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.

Lab Assistant

Medlabs
07.2019 - 07.2020


  • Managed specimen sample handling, receiving, storage and inventory.
  • Logged samples correctly into computerized tracking system.
  • Maintained lab by calibrating equipment and cleaning surfaces and items used.
  • Enhanced laboratory efficiency by maintaining and organizing equipment, supplies, and samples.
  • Conducted quality control tests and assisted in developing experimental protocols.
  • Prepared and analyzed samples, maintaining accurate laboratory records.
  • Ensured compliance with safety guidelines for hazardous material disposal.

Education

High School Diploma -

Manhattan Comprehensive Night & Day High School
Manhattan, NY
08-2012

Skills

  • Technical Expertise: MES PAS-X, SAP, Microsoft Office Suite, Adobe Acrobat
  • Quality Assurance: SOP Development, Batch Record Review, GMP Compliance, Regulatory Compliance
  • Project Support: Workflow Optimization, Data Management, Documentation Control, Reporting
  • Soft Skills: Team Collaboration, Training Development, Problem-Solving, Time Management
  • Specialized Knowledge: Aseptic Manufacturing, FDA Regulations, ISO 13485, EU IVDR

Timeline

Document Specialist II

Stepan
02.2024 - 11.2024

Quality Assurance Specialist

American Spraytech
03.2023 - 01.2024

MES Design Assistant /Senior Quality Assurance Specialist

Ashland Chemical
02.2021 - 02.2023

Quality Control Inspector

Roche Pharmaceuticals
07.2020 - 02.2021

Lab Assistant

Medlabs
07.2019 - 07.2020

High School Diploma -

Manhattan Comprehensive Night & Day High School

Similar Profiles

CREATE PROFILE
Astride Noncent