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Lab Assistant Affairs Specialist

Location:
Washington, DC
Salary:
100000
Posted:
June 04, 2023

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Resume:

Patrick O. Saunders

**** ******** **. ***. ***, Allentown PA, 18105

1-484-***-****

adxiah@r.postjobfree.com

Professional Statement

As the Quality Manager, I am responsible for managing Quality Assurance agendas establishing, implementing and monitoring Food safety and quality programs, including regulatory and customer audits. Continuously drive statistical analysis to improve KPI’s, Cpk’s and Cp’s. Work alongside, Production and Process Mechanics to improve the quality of the product and drive efficiencies. Continuously drive the plant towards a customer-centric attitude through training and education to improve on quality and production.

Education

Western Michigan University, Kalamazoo, Michigan Graduated – May 2015

Bachelor’s degree- Biological Sciences - emphasis in Microbiology/Molecular Biology and Chemistry.

Lean Six Sigma Yellow Belt Certified - Management and Strategy Institute June, 2021

ISO 22000:2018 Internal Auditor Certified – SGS Academy August, 2020

ISO 9001:2015 Internal Auditor Certified – SGS Academy August, 2020

Certificate of Cheesemaker – Center for Dairy Research - University of Wisconsin Madison March, 2020

Certified Kaizen Facilitator – Management and Strategy Institute December, 2019

5S Concept Certified - Management and Strategy Institute November, 2019

Project Management Essentials Certified - Management and Strategy Institute September, 2019

Lean Six Sigma White Belt Certified - Management and Strategy Institute September, 2019

Appendix N Certified – Indiana Board of Animal Health September, 2018

PCQI Certified – FSPCA July, 2018

SQF Certified – NSF December, 2017

Employment

Alpla Inc. PA May 2020 - Present

Quality Assurance Manager May 2020 - Present

Alpla Inc., Bethlehem PA 18015

Responsibilities as the Quality Manger include but not limited to the following:

Help shape and improve quality through statistical analysis (Cpk, KPI, Cp)

oInternal testing accuracy increased (Gauge R&R)

oMeasurement and testing outcomes, Cp and Cpk values increased by 22%

Gauge R&R, new SOP’s, Quality technician Training, statistical use for PM scheduling

Enforce and oversee all quality programs (Food Safety, GMP, PPE, Chemical, Suppliers, raw material, mock recalls, traceability etc.)

Create and maintain CAPA, SCAR, RCA and microbial programs regarding Food Safety

Maintain audit ready status; direct and lead any internal, external or 3rd party audits (FSSC, ISO, FDA, Customer)

oAudit scores increased by 30% overall with fewer findings

Direct and develop a team consisting of 4 shift supervisors and 4 Quality Technicians

oThree of the Four technicians have moved in a QA Tech II position

Helped streamline production, implement and install 5 additional production lines while decreasing customer complaints by 40%.

oTraining and Retention Program

Decrease product on hold by over 50%

Enhanced training through Alchemy System

Michigan Milk Producers Association, MI and IN Feb. 2017 – May. 2020

Quality Assurance Manager Mar. 2019 – May 2020

MMPA/Middlebury Cheese Company LLC., Middlebury, IN

Responsibilities as the Quality Manger include but not limited to the following:

Lead and develop a direct report team of (4) Supervisors to include two production, sanitation and quality along with 2 Laboratory technicians

Increased SQF level II score from start of 87 to most recent excellent rating of 97

Oversee, implement and maintain quality programs related to vendor certification, raw materials, product mock recall, hold and release, food safety and quality programs

Data analysis and trending to improve quality (KPI’s regarding quality, supplier, customer complaints)

Development and maintain all food safety/regulatory programs to meet FDA/USDA/State regulatory requirements

Oversee employee training for Food safety, GMPs, PPE, Chemical Safety

Drove the plant into 21st century with Application powered Internal Audits and new ERP system

Successfully managed External, Customer, Internal and 3rd Party Audits (FDA, IBOAH, USDA, SQF)

Quality System Supervisor, Ovid, MI Nov. 2017 – Mar. 2019

Managed laboratory with 9 direct reports

Oversaw plant training for SQF, FSMA and Food Safety for 200 employee facility

Act as SQF coordinator for the facility

Review and revise all plant documentation (SOP, SSOP, HACCP, daily production documents)

Quality and Regulatory Affairs Specialist, Novi, MI Feb. 2017 - Nov. 2017

Assist the Director of Quality in any way possible while learning the quality systems at our manufacturing facilities.

Assistance to include PMO, FSMA and SQF regulations.

Gathered regulatory knowledge regarding the dairy industry (FDA, USDA, PMO).

Communicate with Customers as to product specifications and required documentation.

Support business with Sales initiatives regarding projects, licensing and certifications.

Amway Headquarters, Ada, MI May. 2015 - Feb. 2017

Product Safety/Regulatory Technician

Break down chemical content to determine the safety behind the formula through scientific research documents.

Technical Skills

Advanced skills: Microsoft Word, Excel, PowerPoint, Access, Dynamic 365 ERP System, SAP, Oracle and scientific databases to collect information in keeping compliant with all regulatory agencies.

Research Experience

November 2013- July 2015: Lab assistant in a microbiology research lab. This project analyzed microbial communities involved in bioremediation of an underground petroleum spill.

September 2012- November 2013: Lab assistant in a molecular/microbiology research lab. Main goal within the lab: Identification of cellular targets of Yersinia pestis (plague). The goal is to understand the structure/function relationship of protein toxins of the plague responsible for inactivation of immune cells during infection.

Volunteer

Operation Warmth, Grand Rapids, MI. Dec. 2010 - Dec.2019

Bid for Bachelors and Bachelorettes, Grand Rapids, MI Nov. 2015 - Mar. 2017



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