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Quality Assurance Manager

Location:
Grand Rapids, MI
Salary:
$120,000
Posted:
April 21, 2023

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Resume:

Nathan T. Sierra

**** ******* ** **, ******* MI *9306 616-***-**** adwocn@r.postjobfree.com

Professional Experience:

Americhem, Grand Rapids M Jan 2022 - Present

Quality Manager

● Managed Tier 2 automotive quality department (2 direct reports and 6 employees) testing TPE and PVC custom color compounds

● Reduced customer complaints by 43% YOY and reduced customer product returns by 47% YOY by improving internal testing, updating customer formulas and addressing root cause deficiencies via 5 WHY, Fishbone Diagrams, PDCA, and other problem solving tools

● Management representative for the oversight of IATF/TS 16949, ISO 9001 and ISO 17025 auditing bodies for recertification

● Oversaw equipment calibration program for 450+ items and improved the review/update of the program

● Improved PPAP submission and approval process by 38% YOY

● Reduced DPMO by 60% from the last 2 year with record sales in 2022 Leprino Foods, Allendale M Apr 2019 - Jan 2022

Quality Execution Manager

● Managed cGMP quality department (2 direct reports and 32 employees) testing mozzarella pizza cheese and dried whey powder

● Led process improvements to increase testing efficiency 47%, reduced annual overtime $75,000/fiscal year YOY, and 5S the main laboratory to improve inventory cycle counts and reduce lab inventory $50,000.

● Management representative appoint to the oversight of FDA, USDA, MDARD, and SQF 9.0 auditing bodies and led the site to achieve certification under the new SQF 9.0 standards

● Received recertification training for SQF and obtained PCQI certification Thermo Fisher Scientific, Kalamazoo MI Mar 2017 - Mar 2019 Quality Assurance Manager, Anatomical Pathology Division

● Managed cGMP/GLP quality department (7 direct reports, 7 scientists, 6 technicians, 1 lab manager and 1 supervisor) testing chemicals, slides and instruments used to diagnose cancer

● Led quality focused process improvements for the following: inspection process, laboratory throughput increase, CAPA process redesign and batch packet Right First Time (RFT) increase through the Practical Process Improvement methodology

● Responsible for the implementation of new processes for Change Control to improve compliance and throughput

● Management representative appoint to the oversight of ISO 90001 and ISO 13485 quality systems and led the site to achieve certification under both new standards

● Management liaison with external parties on matters relating to the APD Quality Management System

● Drive improvements in customer complaint awareness and response through the roll out of new software systems and expansion of scope to division wide coordination

Amway, Ada MI

Physical Quality Control Supervisor Oct 2014 - Oct 2016

● Responsible for the daily throughput of sampling and testing of physical components used across 7 business lines

● Managed cGMP/GLP component lab (10 direct reports including technicians, associate scientists and senior scientists) testing cosmetic, nutrition and home care product components

● Maintained ISO/IEC 17025 certification as well as specific internal and contract customer requirements

● Implemented LEAN systems within the lab to reduce test times by 40% resulting in over $500,000 annual savings

● Co-lead project to procure capital funding for a state of the art electronic scanning system to test print on components and labels sold globally for accuracy and compliance with federal regulations Quality Control Laboratory Supervisor Jan 2014 - Oct 2014

● Created design layout, construction plan and procured $3 million capital funding for a best-in-class QC chemistry laboratory encompassing 21,000 sq.ft. to support a newly constructed manufacturing facility

● Utilized LEAN Six Sigma tools to reduce 1,000 miles of walking annually for staff and improve test throughput

● Created, developed and approved all food safety related programs and policies for compliance with FDA, USDA, MDoA, TGA, NSF and HALAL/IFANCA regulations

● Reviewed and approved over 200 equipment/process/packaging validation protocols and helped ensure validation activities were executed in conjunction with overall project timelines as to not create a delay in start-up Quality Control Principle Engineer Oct 2011 - Jan 2014

● Provided leadership and food safety related guidance during the start up of a new production facility

● Assisted manufacturing with critical issues and resolutions related to environmental monitoring (EM) deviations during cleaning validations and run length validations of all newly installed equipment

● Exhibited exemplary technical writing skills by authoring microbiology investigation reports and program summaries, writing Change Control requests, writing trend reports, writing HACCP plans, writing policies, procedures, SSOPs, SOPs and SW for both in-lab processes as well as manufacturing processes

● Proficient in LIMS, STARLiMS, JD Edwards, ORACLE and other quality/product tracking related software systems Basic American Foods, Blackfoot, ID Oct 2008 - Oct 2011 Quality Assurance Manager

● Oversaw the daily throughput of testing for raw materials, in process samples and finished goods in the Chemistry Lab in accordance with Safe Quality Foods (SQF) requirements, government and contract customer requirements

● Managed cGMP/GLP chemistry lab (16 direct reports including 12 technicians and 4 team leaders) testing potato based food products for retail, bulk and private sales

● Co-managed the chemistry lab, microbiology lab and sampling process for a large scale USDA inspected soup manufacturing company that was acquired out of state while successfully maintaining current responsibilities Heinz Frozen Foods, Pocatello, ID Jun 2004 - Oct 2008 Quality Assurance Lead Microbiologist

● Managed the daily workload of microbiology technicians responsible for gathering raw material samples, in-line samples, EM swabs and finished goods samples to be tested for microbial content

● Participated in the transfer of an RTE manufacturing line relocation from California to Idaho; oversaw the EM impact of construction process, and assisted with the sanitary design of new manufacturing equipment

● Implemented a newly created third shift QA inspection process and hired 5 new technicians to inspect 14 different manufacturing lines prior to the daily USDA inspections before start-up. This process improved right first time (RFT) startup from 63% to 94%, decreased cross-contamination issues 78%

● Obtained advanced HACCP training from the FDA

Idaho State University, Pocatello, ID Aug 1998 - May 2004 BS, Microbiology

● Student Government Finance Chair (2 consecutive terms)

● Student Government Senator for College of Health Professions

● President of the Hispanic Awareness Leadership Organization (HALO)

● Research Apprentice Program Member (researched chemotherapy treatments of rats with colon cancer in outer space in conjunction with the NASA program)



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