Summary
Overview
Work History
Education
Skills
References
Certification
Timeline
Generic

Stephanie Romero

North Babylon

Summary

Proactive and energetic individual with a positive attitude to work on Quality Assurance field.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Supervisor Facility Quality

Nestle Health Science
Bohemia
03.2021 - Current
  • Adhering to the Standard Operating Procedure (SOPs) and Good Manufacturing Practices (cGMPs) that are in effect assuring the quality and quantity of product produced.
  • Assists management with the development of new and revised SOPs, executes validation and qualification studies, performs investigations, and other assignments as required.
  • Handles Change Controls, Deviations, Corrective Actions and Preventive Actions (CAPA) through effective quality management tools.
  • Trains, supervises, and evaluates the performance of QA inspectors to assure compliance with Standard Operating Procedures (SOPs).
  • Responsible for scheduling and coordinating daily priorities for incoming raw material, in-process packaging/labeling, and inspection activities.
  • Review the performance of all QA inspectors in the shift as and when directed by HR.

SUPERVISOR, RA/QA LABELING

PL DEVELOPMENTS
Westbury
01.2019 - 01.2020
  • Ensure all labeling is develop according Title 21-CFR 101 and 201.66
  • Work with creative service to ensure timely development and approval of ANDA, OTC and supplement labeling
  • Oversee QA Proofreaders /Labeling Coordinators
  • Verify QA proofreading procedures are followed

QA LABEL coordinator

PL DEVELOPMENTS
Westbury
01.2016 - 01.2019
  • Proof all Company printed materials including individuals folding cartons (IFCs), labels, displays, inserts, mats, brochures, flyers, sales sheets, mockups, SOP’s and other various company documents against relevant CFR’s

quality associate

PL DEVELOPMENTS
Westbury
01.2013 - 01.2016
  • In charge of running reports to control NCMRs, Open CAPAs
  • Reviewing training status for department personnel and creating training classes for missing, needed associates
  • Using SCAN TVS-CS approved artwork, CNRs for labeling

quality control

PL DEVELOPMENTS
Westbury
01.2011 - 01.2013
  • Oversee receiving area
  • Inspect product labels according to Company’s standards
  • Pick orders and produce barcode labels for products and do release labels stickers for same
  • Deal with quality control supervisors, floor managers and line supervisors

line supervisor

PL DEVELOPMENTS
Westbury
01.2010 - 01.2011
  • Assist line supervisor
  • Pick-up labels to run product on machines
  • Check lots and expiration dates
  • Check machines for left over product
  • Check fillers
  • Take control of production when Line Supervisor is away from the line

Education

ENGLISH AS SECOND LENGUAGE -

nassau community college
garden city, ny
01.2008

Skills

  • Team leader and player who can successfully meet the organization's goals within a stipulated time frame
  • Multitask and adapt to a rapidly changing environment
  • Lead, coach, and supervise the team with flexibility
  • Adobe Illustrator
  • Oracle
  • Agile
  • SCAN TVs
  • Global Vision proofreading software
  • FDA/cGMP guidelines
  • Label development
  • Label control
  • Good documentation practices
  • NDA
  • OTC supplement labeling requirements
  • The FDA issued guidance documents
  • Bilingual English/Spanish

References

References available upon request.

Certification

Food Safety Preventive Controls alliance.

Timeline

Supervisor Facility Quality

Nestle Health Science
03.2021 - Current

SUPERVISOR, RA/QA LABELING

PL DEVELOPMENTS
01.2019 - 01.2020

QA LABEL coordinator

PL DEVELOPMENTS
01.2016 - 01.2019

quality associate

PL DEVELOPMENTS
01.2013 - 01.2016

quality control

PL DEVELOPMENTS
01.2011 - 01.2013

line supervisor

PL DEVELOPMENTS
01.2010 - 01.2011

ENGLISH AS SECOND LENGUAGE -

nassau community college

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Stephanie Romero