Summary
Overview
Work History
Education
Skills
Timeline
Generic

Natasha Mitcham

Chicago,IL

Summary

Proven QA Manager at Salud Natural Entrepreneur, Inc., adept in Agile methodologies and cross-functional team leadership, significantly enhanced product quality and customer satisfaction. Skilled in process improvement and risk assessment, I spearheaded initiatives that streamlined testing and compliance, leveraging my expertise in quality assurance and team building to drive operational excellence.

Overview

14
14
years of professional experience

Work History

QA Manager

Salud Natural Entrepreneur, Inc.
04.2024 - 08.2024
  • Increased customer satisfaction with products by ensuring consistent quality across all platforms and devices.
  • Streamlined bug reporting process, expediting resolution times for critical issues.
  • Optimized test case coverage by identifying gaps in existing test plans and devising new strategies for comprehensive testing.
  • Promoted continuous learning within the QA department through regular workshops and trainings focused on evolving industry best practices.
  • Manage CAPA, Change Requests and Exception Event documentation using QMS.
  • Initiated, and documented non-conformances in EE, CAPA and CR reports using risk management tools FMEA, DMAIC and Ishikawa (Fishbone). Managed direct reports and addressed concerns on the production floor. Monitored inventory, products and projects according to prioritized deadlines. Trained quality staff, improved product testing processes, managed QC holds, extensions and approval of Raw Materials and Finished Products. Implemented continuous improvements within documents, process and training.
  • Developed, implemented and managed processes to ensure products meet required specifications including release of products. Identified and established appropriate quality standards and parameters for products.
  • Managed the daily workflow and schedules of the department. Reorganized schedules to meet deadline changes and updates including in Management Review meetings. Ensured compliance with training and packaging and labeling products.
  • Supervised the production floor, verified and approved the product labels. Printed all current approved master manufacturing records (cleaning, sampling and rework) for production to commence. Signed master batch and packaging records for QA verification during and after production. Managed incoming and outgoing deliveries and applied a team approach, maintaining open communication.

Demonstrator

Advantage Solutions
06.2023 - 11.2023

Experience in sales and marketing providing advertisement of products, allergens for consumer awareness, proper sanitation and handling of foods during demonstration ensuring customer satisfaction and regulations of food handling guidelines.

Maintained product in proper controlled storage conditions, with routine temperature monitoring and documentation, some supply chain and procurement inventory and communication to warehouse personnel. Food Safety And Handling certifications completed.


LIMS Administrator

Fresenius Kabi
01.2015 - 01.2022

Implemented, configured and maintained functionality of LIMS. Complied with SOP’s, performed troubleshooting of the LIMS system. Created new product configurations, updated existing product configurations and tracked current version changes in Documentum.

ERP systems (SAP) used for investigation of raw material components in finished product material.

Worked with Document Coordinators and the Quality Assurance team to ensure GLP and GMP requirements of the LIMS system procedures were accurate. Developed LIMS training modules using cross functional training. Collaborated as a qualified trainer with the Document Control department and colleagues to ensure proper documentation is fulfilled prior to training sessions.

Supported site changes, global change management and validation process. (test scripts)

Ensured administrative management functions-Quarterly Change Request, and assisted the manager with annual LIMS periodic reviews to maintain compliance of users' access.

Sr. Quality Assurance Specialist

Abbott Laboratories
03.2010 - 03.2014

Led, documented and supported monthly audits, then transitioned documents through an IBM interface system for the facility reviewer.

Prepared, maintained, and monitored quality system records establishing consistency in application while leading a project with a limited scope where quality decisions were coordinated between different quality and other functional areas.

Performed sampling, inspecting, testing and dispositioning of incoming commodities, in-process and finished product, stabilities and complaints per specifications or protocol. Analyzed data, evaluated results, and drew conclusions with disposition of material that involved initiating and performing investigations per OOS or nonconformance through Exception Events, Change Request and/or CAPA documentation.

Maintained certification in assigned job responsibilities and completed timely LMS training while performing daily operations, data management, problem solving and process and/or continuous improvements.

Implemented, maintained and supported the quality policy and ensured compliance to site level policies and procedures through individual and team contribution.

GLP applied consisting of ordering, CR Closeout audits and disposal of hazardous materials in the Chemistry Lab using MSDS and CHAP as part of the EH&S Program.

Trained and updated existing SOPs through change management control to align work instructions in compliance with federal regulations.


Education

Bachelor's Of Science - Biology

Loyola University of Chicago
Chicago, IL

Skills

  • Agile methodologies proficiency
  • Quality assurance expertise
  • Process improvement strategies
  • Test strategy development
  • Regression testing management
  • Continuous improvement implementation
  • Cross-functional team leadership
  • Quality assurance background
  • Quality testing
  • Presentations
  • Quality control tests
  • Problem-solving abilities
  • Multitasking
  • QA documentation
  • Quality assurance experience
  • Team Leadership
  • Quality Control Management
  • Team building
  • Quality Inspection
  • Documentation Control
  • Continuous improvement strategies
  • Conflict Resolution
  • Training and Development
  • Risk Assessment
  • Strategic Planning
  • Inventory Control
  • Time management abilities
  • Project Management
  • Workflow Optimization
  • Production Planning
  • Process Validation
  • Problem-solving aptitude
  • Testing Procedures
  • ISO Standards
  • Process Improvement
  • Root Cause Analysis
  • Lean manufacturing principles
  • Performance Metrics
  • Data Interpretation
  • Technical reporting
  • Corrective Action Planning
  • Budget Management
  • Cross-Functional Collaboration
  • Change Management
  • Vendor Management
  • Regulatory Compliance
  • QMS
  • Test management
  • Six Sigma Methodologies
  • Process Automation
  • Conformance monitoring
  • Communication Skills
  • Develop product specifications
  • Cost-reduction strategies
  • Analyze test results
  • Write reports
  • Resolve defects
  • Controls system maintenance
  • Manufacturing operations oversight
  • Process Mapping
  • Resource Management
  • Multitasking Abilities
  • Reliability
  • Quality assurance guidance
  • Organizational performance evaluation
  • QA reporting
  • Defect tracking
  • Deficiency detection
  • SAS
  • Pre-implementation audits
  • Software testing
  • Professionalism
  • Operational Efficiency
  • Equipment Calibration
  • Quality Assurance
  • Performance monitoring
  • Sample products
  • Train staff
  • Adaptability

Timeline

QA Manager

Salud Natural Entrepreneur, Inc.
04.2024 - 08.2024

Demonstrator

Advantage Solutions
06.2023 - 11.2023

LIMS Administrator

Fresenius Kabi
01.2015 - 01.2022

Sr. Quality Assurance Specialist

Abbott Laboratories
03.2010 - 03.2014

Bachelor's Of Science - Biology

Loyola University of Chicago
Natasha Mitcham