Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Timeline
Generic
Sharlene R. Hedge

Sharlene R. Hedge

Crest Hill

Summary

Quality assurance professional with extensive experience at Nutrivo LLC, specializing in regulatory compliance and training initiatives. Demonstrated success in document review and inspection management, promoting a culture of quality and continuous improvement. Expertise in GMP practices and leadership, enhancing operational excellence in manufacturing environments.

Overview

12
12
years of professional experience

Work History

Clerical Receptionist - Administration

Sunny Hill Nursing Home of Will County
Joliet
04.2022 - 05.2024
  • Offered administrative assistance in a healthcare environment, handling communication, visitor screening, and maintaining records.
  • Managed inbound and outbound calls, ensuring effective communication across the facility.
  • Oversaw COVID-19 screening procedures and managed kiosk systems for staff and visitor check-ins.
  • Handled resident care plan distribution, mail sorting, and key management to ensure smooth facility operations.
  • Handled financial transactions such as cash, checks, and petty cash, ensuring records were kept accurate and up to date.

Quality Assurance Specialist

Nutrivo LLC
Aurora
01.2017 - 02.2021
  • Oversaw final inspection of batch documentation for supplement manufacturing, ensuring compliance with quality standards.
  • Conducted final inspections of batch documentation for blending and packaging processes.
  • Developed and trained staff on SOPs, quality work forms, and batch record procedures, supporting startup operations.
  • Participated in FDA audits and scheduled inspections, ensuring regulatory compliance.
  • Managed gluten testing, document retention, and electronic filing of quality records.
  • Reviewed specifications and Certificates of Analysis (COA), ensuring product quality and compliance.
  • Trained employees on GDP, GMP, and change control procedures, fostering a culture of quality.

Quality Control/Laboratory Technician

Glanbia Performance Nutrition
Aurora
01.2014 - 12.2016
  • Led daily quality assurance activities in manufacturing, including inspections, testing, and investigation of product holds.
  • Performed visual inspections, allergen verification, and microbiological testing to ensure product safety.
  • Conducted X-ray, metal detection, ATP swabs, and density testing to verify product integrity.
  • Reviewed formulas, ingredient checks, and micro sampling for compliance.

Quality Control/Laboratory Technician

Peacock Engineering Co.
Geneva
01.2014 - 12.2016
  • Managed daily quality control inspections and testing in a manufacturing environment.
  • Conducted visual inspections, cleaning checks, and calibration of equipment.
  • Performed density, water activity, moisture, leak/seal testing, and metal detection.
  • Maintained laboratory documentation, organization, and cleanliness.

Quality Control Laboratory Technician & Trainer

Excel Company Power Packaging
Batavia
01.2012 - 12.2014
  • Ensured batch quality through testing and inspections, and trained staff on laboratory procedures.
  • Conducted ATP testing, visual inspections, and calibration of measurement devices.
  • Tested batches for density, pH, salt, moisture, and viscosity, ensuring compliance with standards.
  • Oversaw laboratory operations, participated in audits, and trained staff on GMP, GDP, and CCP.

Education

High School Diploma - general education

Glenbard East High School
Lombard, IL
02-2009

Skills

  • Quality assurance
  • Compliance
  • Document review
  • Auditing
  • Regulatory standards
  • Laboratory QA
  • Manufacturing QA
  • Training
  • Leadership
  • Batch records
  • Electronic records
  • Inspection management
  • Audit management
  • GMP practices
  • GDP practices
  • Process improvement

Accomplishments

  • Led the development and implementation of the Final Inspection Department at Nutrivo LLC, enhancing documentation accuracy and audit readiness.
  • Trained and mentored QA and manufacturing staff on batch record procedures, GMP, and GDP, resulting in improved compliance and operational efficiency.
  • Successfully participated in FDA inspections and scheduled audits, ensuring adherence to regulatory requirements and facilitating smooth audit processes.

Affiliations

  • Reading, exploring, singing, and enjoying nature.

Timeline

Clerical Receptionist - Administration

Sunny Hill Nursing Home of Will County
04.2022 - 05.2024

Quality Assurance Specialist

Nutrivo LLC
01.2017 - 02.2021

Quality Control/Laboratory Technician

Glanbia Performance Nutrition
01.2014 - 12.2016

Quality Control/Laboratory Technician

Peacock Engineering Co.
01.2014 - 12.2016

Quality Control Laboratory Technician & Trainer

Excel Company Power Packaging
01.2012 - 12.2014

High School Diploma - general education

Glenbard East High School

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