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Sharlene
kesslersharlene@gmail.com
715-441-6858
5662 Baxter Lake Dr.
Jacksonville, FL 32258
Quality Assurance Manager
29 years experience W2
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Average rating
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Summary

  • A discerning and diligent professional with over 25 years of experience in defining, measuring and reporting key performance indicators to measure and improve quality, efficiency and effectiveness, while guiding team processes, and ensuring consistency, transparency and optimization to foster continuous improvement in accordance with corporate strategy.
  • Proficient in managing project information to support team decision-making, planning, execution and tracking of Scientific Affairs activities.
  • Able to manage global initiatives in a matrix organization; support objectives - training, access programs, studies; and contribute toward publications.
  • Eminent in analyzing samples and interpreting results; compiling information and results into meaningful formats to ensure content is appropriately represented and maintaining records long term.
  • Efficient in preparing reports of completed projects for publication in technical journals, for presentation at conferences, or for use in further research activities.

SKILL AREAS:

  • Strategic Planning
  • Project Management & Scheduling
  • Business Development
  • Client Relations
  • Revenue Growth
  • Statistical Analysis
  • Six Sigma Green Belt
  • Certified Graduate Internal Auditor
  • CAPA
  • Gap Analysis
  • Risk Management
  • Promote Creative Solutions
  • Conformance Quality & Manufacturability
  • cGMP/GLP Data Compilation & Analysis
  • Conflict Resolution

Experience
Quality Assurance Manager
Information Technology
Jun 2020 - present
Jacksonville, FL
  • Independently devised a Quality Management System (QMS) to be compliant with 21 CFR 111 for nutraceuticals, skin care and liquid consumables.
  • Responsible for implementation and execution of company QMS.
  • Provide guidance and direction to Production, Operations and Fulfillment Department personnel.
  • Evaluate the effectiveness of the QMS and make recommendations to improve performance while optimizing system efficiency.
  • Institute training in Quality concepts, principles, and drive change.
  • Lead non-conformance and CAPA investigations using Root Cause Analysis techniques and leading to sustainable corrective actions
  • Provide solutions and set precedent.
Project Management
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Multiple Roles
Information Technology
Mar 2006 - Oct 2019
Minneapolis, MN
  • Manage individual projects from feasibility through to new product launch; add new product initiatives and provide products and services as per SOPs which are consistent with cGxPs
  • Responsible for the verification and research of issues by utilizing data-based facts as well as the implementation of action plans via interdepartmental coordination concerning competing priorities and time constraints
  • Safeguard compliance to ISO 9001:2015, ISO 13485:2016, and ISO 14001:2015 standards by performing internal audits/CAPA/remediation; conflict resolution of non-conformance/complaint investigation from customers, manufacturing and QC
  • Participate in data compilation and analysis and offer technical reports, summaries, and data analysis; ensure developed ELISA test kits perform according to the design goals as stated in company SOPs
  • Deliver help/conduct tests in early stage clinical studies in a cGXP environment
  • Increased average sales by over $500k per year to date with new products
  • Industrialized and closed new NPI projects and safeguarded conformance quality and manufacturability for NPI
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Research Associate
Information Technology
Aug 2011 - Jul 2013

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Research Associate, Validation
Information Technology
Mar 2006 - Mar 2006
Minneapolis, MN

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Lab Analyst
Information Technology
Jul 2001 - Nov 2003
River Falls, WI

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Inside Sales Representative
Information Technology
Aug 1992 - Jul 1995
Batavia, IL

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Edit Skills
Non-cloudteam Skill
Education
Master's in Project Management
Louisiana State University
Bachelor's in Biology
DePaul University
Business Administration
DePaul University
Natural Science Wm
Rainey Harper College
Certifications
Scheduling * Business Development * Client Relations * Revenue Growth * Statistical Analysis * Six S
Skills
Auditing
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1
Project Management
2021
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Regulatory Reporting
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1
Risk Management
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