Regulatory Affairs and Supplier Quality Assurance - Manufacturing Resu
Regulatory Affairs and Supplier Quality Assurance - Manufacturing Resu
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Regulatory Affairs and Supplier Quality Assurance Resume

Desired Industry: Manufacturing SpiderID: 82516
Desired Job Location: Downers Grove, Illinois Date Posted: 3/19/2020
Type of Position: Full-Time Permanent Availability Date: Immediate
Desired Wage: Open
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: No
Highest Degree Attained: Doctoral Willing to Relocate: No

Forward-thinking, challenge-driven, and results-oriented professional, offering broad-based experience in regulatory affairs and supplier quality assurance within multinational corporations.


Associate Principal Scientist, Global Supplier Quality Assurance (GSQA)  Dec 2018–Mar 2020
 Drove efficiency improvements and harmonized ways of working while simultaneously mitigated liabilities and strengthened business capabilities through technical advisement and a faster, better, stronger business mindset.
Career Highlights:
 Implemented data-driven performance metrics and key performance indicators (KPIs) to deliver related insights to executive GSQA leadership seeking to drive significant impact and value across the business
 Designer/developer of global cloud-based single point of truth for up-to-date supplier information to all PepsiCo stakeholders safeguarding safety, regulatory compliance, and specification adherence
 Implemented performance management tracking and scoring capabilities of global concentrate business raw material specification adherence at each port of entry in global supply chain.
 Harmonized global supplier site auditing under a single unified digital platform with built-in task automation, data consolidation, and real-time translation of over sixty languages.
 Assessed over 1100 raw materials for safety, legality, and fit for purpose and completed 131 supplier site audits

Regulatory Affairs Specialist, Regulatory and Legal Affairs, Contract/Consult  May 2018–Dec 2018
 Handled all aspects of regulatory affairs for Bio-Engineered Supplements and Nutrition, Inc. and Isopure, Inc., with task of providing regulatory documentation, nutritional/supplemental facts panels, ingredient declarations, artwork/label approvals, country compliance, import/export, ecommerce support, product suitability, and label claims
 Maintained consistent communication with the Research and Development (R&D) and Marketing departments to ensure alignment of innovation and legacy product development initiatives with respective regulatory jurisdictional compliance, such as Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Official Controls Regulations (EU-OCR)
Career Highlights:
 Improved business continuity by establishing standard operating procedures (SOPs) for FDA compliant nutrition and supplemental facts panel, administering raw materials with heavy metals, and coordinating with finished goods co-manufacturers
 Led the successful mitigation of business liabilities through special projects, including:
o Ensured Food Safety Modernization Act (FSMA) compliance of all raw materials
o Updated amino acid profiles based on most recent finished product formulations; and
o Provided clear system identification of raw material flavors against flavor types

Regulatory Affairs Specialist, Global Functions and Governance Compliance, Contract/Consult  Jul 2015–Jan 2016 | Apr 2017–May 2018
 Acted as the Regulatory Team lead for a seven-person contracted team, in charge of guaranteeing legacy specification adherence to PepsiCo global initiative to organize all raw material technical specifications under one quality and food safety standard
 Ensured compliance of Quaker raw material and finished goods technical specifications with FSMA through supplier outreach to submit updated technical documents for food safety and regulatory compliance
Career Highlights:
 Played an integral role in minimizing the company’s liability on raw material specifications by applying positive influence management approaches on Microbiology, Food Safety, and Quality Assurance teams which drove effective solutions in their areas of expertise
 Expedited supplier documentation requests and sustained the company’s relationship with suppliers by leveraging industry supplier contacts within professional network

Tax and Trade Bureau (TTB) and Technical Regulatory Affairs Specialist, Global Regulatory Affairs  Jan 2016–Apr 2017
 Served as USDA regulatory representative and company point of contact for USDA plant audit inspector inquiries, exhibiting expertise in USDA amenability and Food Safety and Inspection Service (FSIS) label approvals
 Rendered oversight to the regulatory affairs for Savory Business and Harbor Beach, Michigan production facility which represented 25% of the company’s total revenue
 Offered FDA, TTB, and USDA regulatory guidance to key leadership during weekly meetings regarding organizational R&D and product strategy formulation
Career Highlights:
 Generated $350K in alcohol excise tax refunds due to analytical and taste panel justification of more than 700 non-potability TTB claims
 Completed more than 200 generic and 20 prime label FSIS approvals
 Earned commendation for efficiency improvements within the department by optimizing cross-functional ways of working, significantly reducing (~65%) turnaround time of regulatory resolutions to stakeholder needs
 Boosted overall business by creating a SAP module that provided valuable food safety and regulatory information to key stakeholders (i.e. GRAS usage levels, FEMA flavor profiles, CAS, EINECS, etc.)

Food Safety and Regulatory Affairs Specialist, Unilever Foods–Research and Development  Dec 2014–Jul 2015
 Promptly responded to internal and external food safety, quality, and regulatory technical inquiries on technical documentation, analytical methodology and validation, hazard analysis and critical control points (HACCP) and hazard analysis and risk-based preventive controls (HARPC) culpability, plant audits, good manufacturing practices (GMPs), product suitability, country compliance, label claims, generally recognized as safe (GRAS), nutrition, allergens, Prop 65, shelf life, and storage claims
 Signed all Unilever Foods supplier agreements and official statements regarding quality and food safety
 Took charge of preparing, signing, and enforcing the company’s official response to the 2015 industry-wide global peanut-tainted cumin allergy recall
 Acted as the regulatory approving authority for all spreads’ category artwork and labeling
Career Highlight:
 Received the Circle of Excellence Award for mitigating identified traceability gap and automating daily functions resulting in a 70% decrease in turnaround time of technical inquiries

Teaching Assistant, Department of Biological Sciences  Aug 2010–Dec 2014
 Stipend position co-facilitating lecture- and lab-based upper level undergraduate coursework in genetics and microbiology as part of the Ph.D. graduate program in molecular systematics and population genetics.
 Proficient in a variety of molecular, microbiological, and bioinformatics laboratory techniques
 Worked as a student research associate at Pritzker DNA Lab, Field Museum of Natural History in Chicago, IL
 Received Elmer Hadley Graduate Research Award in 2013 and Excellence in Teaching Award in 2011, 2012, and 2013

Behavioral Science Noncommissioned Officer (NCO)  Sep 2002–Feb 2012
 Former military noncommissioned officer (NCO) with 10 years federal service in both leadership and non-leadership roles with experience handling dynamic situations and complex time-sensitive scenarios

Global Food Law Course  Michigan State University, East Lansing, MI: 2016
Ph.D. Candidate - Doctor of Philosophy in Biological Sciences | GPA: 4.0  University of Illinois at Chicago, Chicago, IL
Bachelor of Science in Biological Sciences  University of Illinois at Chicago, Chicago, IL: 2010
Behavioral Science | GPA: 3.8  United States Army–Medical Command, Academy of Health Sciences, San Antonio, TX: 2003

Additional Information:

Foreign Supplier Verification Program  In Progress (Expected Completion: 2020)
Preventative Controls for Human Foods–Preventive Controls Qualified Individual (PCQI) Certification  2017


American Society for Quality (ASQ)

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