Quality Assurance

Luke Davis

Email: abpr7s@r.postjobfree.com

Address: **** ******** *****

City: Columbus

State: OH

Zip: 43230

Country: USA

Phone: 614-***-****

Skill Level: Experienced

Salary Range: $60,000

Willing to Relocate

Primary Skills/Experience:

Adaptability Training and Development Project Management SQF Practitioner

Educational Background:

Bachelors Degree, Political Science

Ohio Dominican University, 06/2004 - 05/2010

Columbus, OH

Job History / Details:

LUKE DAVIS

PRODUCTION / QUALITY SUPERVISOR

4465 Wrangell Place

Columbus, Ohio 43230

H: 614-***-****

M: 614-***-****

abpr7s@r.postjobfree.com

QUALIFICATIONS PROFILE

Production Startup, Expansion, & Optimization

Quality, Process, & Regulatory Improvement

Auditing, Validation, & Compliance Reporting

Quality System Enhancement

Root Cause Analysis

Metrics Tracking & Reporting

Team Training & Leadership

Project Management

* Dedicated 20+-year career evaluating, recommending, and implementing key initiatives that have enhanced productivity, quality, and regulatory compliance for Abbott Nutrition and The Kroger Company.

* Combine excellent analytical, quality, and manufacturing qualifications with achievements in producing products in adherence to established specifications, regulations, and policies.

* Strength in evaluating, defining, introducing, and guiding the adoption of programs, standards, and best practices that have improved throughput, reduced costs, and increased efficiency.

* Talent for building teams, designing and facilitating training programs, and motivating teams to achieve goals. Strong work ethic and unwavering belief in the power and capability of teams and individuals.

Prometric Hazard Analysis Critical Control Points (HACCP) Manager Certification

Safe Quality Foods (SQF) Level 3 Certification

Low Acid Canned Food Production Certification

Abbott Initiator / Evaluator, Investigator, and Resolution Planner Global Quality Management Systems Certifications

PROFESSIONAL EXPERIENCE

ABBOTT NUTRITION, a division of ABBOTT LABORATORIES - Columbus, Ohio, 1995-Present

Earned 5 promotions during tenure with this leading provider of nutritional and related healthcare products. Advanced based on consistent contributions to product quality, process improvement, and regulatory compliance.

Batch Records Coordinator / SQF Practitioner (2010-Present)

Promoted to audit and verify that all departments and processes within the Columbus plant are in adherence to stringent 21 CFR, Safety Quality Foods Institute, Quality Assurance International, Orthodox Union, and Halal regulations. Evaluate new changes to regulations, define and communicate potential risks to departments, and ensure the appropriate implementation of controls and standards to maintain compliance. Conduct procedure, forms, work order, and product line audits. Review and investigate customer complaints.

* Credited with ensuring production, quality assurance labs, maintenance, processing, facilities, and distribution departments are in compliance with policies, procedures, and regulations for infant formula product family.

* Defined, communicated, and oversaw the implementation of procedures to meet new Inventory of Glass and Brittle Plastic regulations.

* Conducted a risk assessment of departments to verify compliance with Safe Quality Foods (SQF) requirements. Documented and presented findings to external auditor that resulted in mitigating the need for 3 daily audits and obtainment of certification.

* Recognized for providing quality system support and ongoing program development for production and process controls, food safety, pest control, and corrective action / preventive action (CAPA).

Batch Records Auditor - Quality Systems Department (2008-2010)

Selected as a core member of team to ensure completeness and correctness of production records for infant formula. Audited and validated accuracy of paper and electronic documents for processing, sterilizing, labeling, and packaging operations against stringent regulatory requirements. Identified and communicated nonconforming products, and records discrepancies, errors, and omissions to proper department.

* Recognized as a subject matter expert (SME) within the aseptic production lines. Solely responsible for ensuring products and production records were in adherence to Infant Formula Act (IFA), Low Acid Food, Food Safety and Quality (HACCP), and Safe Quality Foods (SQF) regulations.

* Chosen as the Batch Records Coordinator to oversee the quarantine and disposal of nonconforming products.

* Developed the Quality System Batch Release Metrics tool that provided an automated means to track the batch records audit and release process.

Aseptic Training Crew Leader / Project Coordinator (2007-2008) / Aseptic Production Specialist (1997-2007)

Chosen as the 1st operator for new aseptic line and the 1st low acid line in the world. Held pivotal role in starting up and expanding production line; training up to 60 production personnel across 3 shifts; conducting quality checks on the integrity of fill weights, temperatures, pressures, flow rates, and seals; resolving quality and production issues; and creating production schedules. Promoted and given cross-functional responsibility to train personnel on processes and operations, provide backup support to production supervisors, and oversee critical projects.

* Core member of team credited with validating and starting up the initial commercial sterilization aseptic line.

* Established a Production Specialist Qualification Program for new production line. Developed standard operating procedures (SOPs) across production, quality, and cleaning operations.

* Resolved failure issue with new oxygen analyzer equipment that delivered $12K-$15K in savings per machine.

* Key contributor in deploying an electronic work order system into the production environment that eliminated human errors. Defined systems functionality for quality and production operations.

* Assisted in developing the Aseptic University to provide quality, maintenance, and engineering personnel with 3-day intensive training on sterilization, microbiology, machine operation, and electronics batch records system. Collaborated with multiple departments-across 5 divisions-to develop and deliver training.

* Planned and oversaw 2 critical process improvement projects that increased efficiency and delivered $12K in savings. Led the fabrication of a walkway between 2 large fillers in the product sterilization room and installation of units to store cleaning supplies in the sterilization and filler rooms.

Label Operator (1996-1997) / Package Equipment Operator (1995-1996)

Brought on to ensure optimal operating effectiveness of package lines producing infant formula and medical nutritionals. Advanced to oversee the labeling production for the pediatric and medical nutritional product families.

* Spearheaded the establishment of a training program for cleaning chemicals that reduced costs by 10% and enabled the achievement of safety guidelines within the Packaging Department. Identified the need, built a group, obtained standard operating procedures from vendor, and delivered training to personnel.

* Identified and collaborated with maintenance personnel to resolve timing issue with labeling machines that increased production from 200-300 to 500 units per minute, resulting in achieving production goals.

THE KROGER COMPANY - Columbus, Ohio, 1990-1995

Bakery Production Team Member - Columbus Plant

Recruited to ensure the appropriate production of bread products in adherence to FDA and corporate standards.

* Team member of 2 credited with recommending and deploying sealant on production floor that increased ease and efficiency of moving large bread racks.

EDUCATION & CREDENTIALS

Bachelor of Arts in Political Science * OHIO DOMINICAN UNIVERSITY - Columbus, Ohio (2010)

magna cum laude; Study Abroad Program in Guatemala, 2009

Certifications, Training, & Professional Membership

* Low Acid Canned Food Production Certification - Ohio State University / Low Acid Food School

* Hazard Analysis Quality Control Points (HACCP) Certification - Prometric

* Global Quality Management System (GQMS) Certifications - Abbott Laboratories

* Safe Quality Foods (SQF) Practitioner / Certification Level 3 - Safe Quality Foods Institute (SQFI)

* Member, Regulatory Affairs Professional Society (RAPS) - Since 2010

Awards & Recognitions

* Abbott Internal Awards - 2011 Pinnacle Award and 1998, 1997, and 1996 C.A.R.E. Team Awards - Abbott Laboratories

* 2006 & 1999 Community Service Awards - Ohio State Senate and Congress

Technology Proficiency

* MS Office Suite (Word, Excel, PowerPoint); Quality Document Management System (QDMS)

* SAP, CAMBAR, AMAPS, and AS/400 Shawware Inventory / Quality Systems

Contact this candidate