Jessica Decker

Kendall, NY ***** 585-***-**** ad3i0z@r.postjobfree.com

EDUCATION

SUNY Upstate Medical University, Syracuse, New York

Master’s Degree in Microbiology, GPA 3.57

Nazareth College, Rochester New York

Bachelor of Science in Biology, Minors: Chemistry, Environmental Science, GPA 3.37

Cornell CALs LeadNY: Leadership Development Fellowship, Cornell University, Class 18

Leadership Fundamentals Graduate

Two year fellowship program through Cornell University for professionals within the food and agricultural sector to improve individual leadership, teambuilding, networking, self-awareness, issue analysis, critical thinking and civic engagement.

Executive MBA, Valar Institue, Quantic School of Business and Technology

Estimated matriculation: July 2024

PROFESSIONAL EXPERIENCE

Nortera Foods (formerly Bonduelle North America), Brockport New York September 2016- present

Quality Systems Manager

-Manages Quality Systems over 3 shifts, 24/6 repack facility, frozen vegetable sector

-Manages Product Quality Associates, Incoming Inspection, and Sanitation teams

-Lead SQF Practitioner

-Lead Food Safety / HACCP Coordinator

- Lead Preventative Controls Qualified Individual (PCQI)

-Inventory Management

-DuPont STOP program trained for employee health and safety, facility Safety Committee participant

-External audit and inspection coordinator, including FDA, Ag & Markets, customer audits, and GFSI

-Management of Internal Auditing Program and Continuous Process Improvement initiatives

- Management of site’s Environmental monitoring program (EMP)

- Maintenance of Organic certification for Organic Production

-Oversees sanitation program and coordinates with chemical supply rep

-Responsible for investigating and responding to customer complaints, and implementing CA

- Manages Incoming inspection QA team and releases incoming product and packaging

-Collaboration with Sales, potential and current customers, raw material suppliers, Supply Chain, and external warehousing

-Responsible for nonconforming product holds and releases, dispositions of product

- Manages QA budget, supplies, professional fees, food safety capital expenditures

-Implemented completely paperless platforms within the facility for all critical records

-Document Control and change control coordination for facility

-RCA investigations and CAPA analysis for nonconformance

-Quality System’s KPI trending and DMS board management: First pass yield, holds and releases, EMP, employee engagement, safety, customer complaints, external audit results

-Quality networking, plant tours, food safety audits and comparison of best practices among 13 Nortera plants in North America

-Volunteer consultant with Food Link in Rochester, NY to assist with their GFSI certification and manages Nortera’s food donation program

-Nortera Brockport’s site lead for Corporate Social Responsibility initiatives and reporting

Baxter Healthcare, Medina New York. June 2015- September 2016

CAPA Quality Associate II

-Identification of nonconformances and corresponding containment activities.

-Investigation of nonconformances, including Root cause analysis.

-Identification and implementation of corrective action to address Root Cause.

-Verification of Effectiveness of Corrective Action.

-Participation in facility audits: Corporate, Internal, Mock, Quality certification audits

-Participation in facility Continuous Improvement and Preventative action efforts

-Presentation of findings to Senior Management for review and approval

-Manage multiple CAPA records and ensure timeliness of completion.

- Change Control Owner and Author of SOPs, Work Instructions, and Quality Work Instructions

-Large scale project management to achieve facility wide corrective actions while adhering to company timeliness goals.

- Assembly and direction of cross functional teams

- Process mapping

- Gap analysis / SWOT analysis

- Change Control Owner

Ortho Clinical Diagnostics (Consultant with Kelly OCG), Rochester, New York. May 2013-June 2015

Scientist I- Verification and Validation, Immunohematology Group

Evaluation of immunohematology instrumentation during integration, verification, validation, and reliability testing phases. Working as part of a cross-functional team to provide solutions for design issues discovered during product development.

-Evaluated and conducted analyzer qualifications and assay/analyzer performance

-GDP/GMP trained

-Daily Quality Control Checks, Calibration and maintenance of analyzers.

-Extensive documentation of maintenance, operation, and quality checks.

-Creation of Runsheet’s for daily testing based on validation testplan and daily QC requirements.

- Subject Matter Expert for ORTHO VISION, ORTHO ProVue® and ORTHO BioVue® automated blood bank analyzers

-Identify and document defects in operating software for further correction.

-Review and approval of operator documentation

-Documentation of discrepancies in analyzer performance.

-Troubleshooting, issue tracking, issue report creation

-Data evaluation and Quality Assurance checks of operator documentation.

-Data tracking with OARS software

-Spreadsheet analysis and macros in Microsoft Excel

Vaccinex, Rochester, New York October 2010- February 2013

Senior Research Associate

-Designed, planned and executed experiments in vivo and in vitro.

-Cell line creation and characterization.

-Data generated supported two FDA submissions for Phase 1 clinical trials.

-Worked as a productive member of multi-disciplinary scientific and regulatory team to reach company goals.

University of Rochester, Rochester, New York March 2009- September 2010

Research Scientist

-Designed, planned and executed experiments in vivo and in vitro.

-Interviewed, trained, managed the workload and scheduled junior members of the lab.

-Extensive troubleshooting, experimental protocol design, and optimization.

-Managed administrative safety and monitoring duties of the lab.

ICON Pharmaceuticals, Whitesboro, New York August 2008-February 2009

Immunoassay Scientist

-Designed and preformed Immunoassays on samples from Clinical Trials.

-Wrote, revised and followed multiple SOPs.

-GMP/GLP trained

SUNY Upstate Medical University, Syracuse, New York August 2006-March 2009

Graduate Research Scientist

Department of Biomedical Sciences, Microbiology and Immunology

Designed and preformed scientific research.

Thesis “The Effects of Heavy Metal Exposure on the Immune System”

University of Rochester, Rochester, New York January 2006-May 2006

Intern Research Scientist

Department of Environmental Science

Research on the role of Cigarette Smoke on Histone Deacetylases, published.

Roswell Park Cancer Institute, Buffalo, New York June 2005-August 2005

Intern Research Scientist

Department of Pharmacology

Research on the role of Histone Deacetylases in Colon Cancer.

Contact this candidate