Sharlene Kessler

**** ****** **** **., ************, FL 32258

Phone: 715-***-****, E-Mail: adb5j0@r.postjobfree.com, projects

https://www.linkedin.com/in/sharlene-kessler-701479b3

Quality - Scientific Affairs

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

PROFESSIONAL EXPERIENCE

Golden Labs, Jacksonville, FL (Jan’20 – Present)

Quality Assurance Manager

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.

R&D Systems, Inc., Minneapolis, MN (Mar’06 – Oct’19)

Multiple Roles

Growth Path

Research Associate, Validation (Jul’13 – Oct’19)

Research Associate, Product Support (Aug’11 – Jul’13)

Research Associate, ELISA Development (Mar’06 – Aug’11)

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

PRIOR EXPERIENCE

P3 Scientific, Oakdale, MN (Apr’04 – Jan’06)

Supervisor of Genetic Profiling Lab/Environmental Monitoring Coordinator/Microbiology Associate

Bio diagnostics, INC., River Falls, WI (Jul’01 – Nov’03)

Lab Analyst

VWR Scientific, Batavia, IL (Aug’92 – Jul’95)

Inside Sales Representative

PROFESSIONAL DEVELOPMENT & CREDENTIALS

Resident Life Including Variable Annuity & Health Insurance Agent

Issued by the State of Florida, Agent # W612676

Master of Business Administration - Project Management Specialization

Louisiana State University – Shreveport, LA

Bachelor of Science - Biology

DePaul University, Chicago, IL

Associate of Arts - Business Administration

Associate of Science - Natural Science

Wm. Rainey Harper College, Palatine, IL

MEMBERSHIPS: Beta Gamma Sigma, Sigma Iota Epsilon, ASQ

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