, , 100 Montgomery St. 10th Floor(555) 432-1000, resumesample@example.com
Summary
Dedicated Quality and Regulatory professional committed to safeguarding human health with 2 years as Pharmaceutical Laboratory Supervisor, providing oversight and general support for manufacturing processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, aseptic process validation, ISO, Customer Audits, cGMP, EPA, and FDAIBAMM/JP regulations compliance. Overseeing activities of Chemist, Microbiologist, and 9 Technicians, providing oversight and general support for manufacturing processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, aseptic process validation, ISO, Customer Audits, cGMP, EPA, and FDAIBAMM/JP regulations compliance.
Skills
Received Sapphire Award for individual contribution to the Product Stewardship Program.
SKILLS
B.S. Degree in Chemistry Quality Management Systems (QMS)
Effective Communication and Training Skills Critical Thinker
Knowledge Current Good Manufacturing Practices (cGMPs) Attention to Detail
Knowledge Good Documentation Practices (GDPs) Good Decision Making and Trouble shooting Skills Solid functional Microsoft Office skills SAP, LIMS, SharePoint
3D, Processes
Attention to Detail, Progress
Auditing, Project Management
Automotive, Quality
Consulting, Quality Management
Clients, QA
Customer care, Research
Decision Making, Risk assessment
Delivery, Safety
Product development, Sales
Direction, SAP
Documentation, S NA
Fashion, Specification
Functional, Teaching
Innovation, Technical training
Latin, Trouble shooting
Law, Written
LIMS
Managing
Market research
Market
Materials
Meetings
Microsoft Excel
Microsoft Office
PowerPoint
Word
New product development
Packaging
Policies
Presentation Skills
Experience
12/2014 to 01/2018Senior Quality ManagerCollins Aerospace | Santa Isabel, PR,
Served as Compliance Gatekeeper for food and beverage packaging, clients such as McDonald’s, Chick-fil-A and Panera.
Oversaw new product / new formulations development for North American and other AOW markets such as Latin America, Asia, Europe, and the Middle East.
Accelerated product development timeline by developing a quantitative risk assessment for portfolio 40 food categories, standardizing the level of regulatory assessment and testing required.
Improved the delivery time of new packaging to market for McDonald’s and other QSRs by 50% through innovative product development strategies leveraging approved materials.
03/2013 to 11/2014Quality ManagerParker-Hannifin, Corporation | Woburn, MA,
Quality liaison to McDonald’s, HAVI product developments, sourcing, and innovation teams.
Created a systematic product development process (Stage Gate), defined quality specifications for all new products, coordinated product testing with suppliers, promoted a strong quality culture.
Spearheaded development of Product Stewardship Program (PST) at HAVI Global Solutions, governing development of compliant food packaging, implemented in record time of 6 months.
Launched over 100 new compliant products for McDonald’s and other QSRs in first year of PST Program,
In over 30K restaurants, produced at over 100 supplier locations.
Bestowed Sapphire Award for individual contribution to the Product Stewardship Program
Developed and launched over 40 new food contact items as member of product development team.
Accelerated time to market 30% by embedding APQP into the Stage Gate Process.
12/2004 to 02/2013Quality Manager-ISO RepresentativeHENKEL CORPORATION | City, STATE,
Site production14Million lbs./yr.
Hazardous and non-hazardous, industrial-food contact-medical grade coatings and adhesives.
Assisted and gave direction to the organization to produce products that meets or exceeds all specifications and requirements by utilizing the QC staff and experience while staying within all local and Federal regulations.
Supervised the day-to-day operation of the Quality Team and laboratory and ensure compliance to requirements and procedures.
Maintain a clean, orderly, and safe laboratory environment.
Manage the design, implementation, and continuing control of the company quality systems requirements for the site.
Ensure compliance to applicable quality system standards.
Manage formulation and implementation of written procedures associated with the quality system or quality related processes.
Manage communication of quality issues to the business and coordinate teams to work on resolution.
Facilitate/Lead 8D & 3D corrective actions.
Manage communication of plans, actions, and controls to customers or sales, as appropriate.
Set goal and track progress to Time-to-Closure for customer concerns and INCAR’s.
Lead/Manage projects/teams to improve operations in areas like scrap causes, customer complaints, field failures, etc.
Drive continual improvement of our quality-related metrics.
Define Critical to Quality criteria.
Assist in managing policies and procedures.
Provide resources in the auditing and correction action processes.
Lead laboratory investigations for claims and customer requested investigations and coordinate responses to customer corrective actions in a timely fashion.
Provided direction for the day-to-day operation of the QC lab and manufacturing, ensuring efficient turnaround time for batch release while maintaining the quality of analysis.
Practiced environmental safety through proper PPE, procedures, training and appropriate handling and disposal of hazardous materials.
Managed site compliance readiness activities to always ensure inspection readiness.
Worked with customer care, r&d and operations teams to resolve and assist in customer/consumer complaints, internal concerns, and new product development and processing.
Achievements.
Achieved 99.1% first time production QC pass.
Reduced customer complaints in one year from 47 to 18 through root cause investigations and CAPAs.
Supported transition from paper QMS to EQMS by authoring, reviewing, approving over 100 SOPs.
Provided 24/6 production support by supporting quality team of 5 QC/QA technicians.
Implemented 5S in the QC Lab and supported efforts for implementation throughout the plant.
Identified deviations in finished products from quality standards, isolating causes within production process and devising solutions to increase consistency.
Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
Education and Training
Expected in 2017
RAC Certification In-progress
Disruption in Globalization
| , , GPA:
Expected in 2015
Keller and Heckman-Food Safety
| , , GPA:
Expected in 2015
Project Management Overview
| , , GPA:
Expected in 2014
Keller and Heckman-Food Packaging Law
| , , GPA:
Expected in 2014
Keller and Heckman-FDA Regulations
| , , GPA:
Expected in 2013
Henkel’s NA Food-Safe Packaging Forum 2013, 2017
Effective Presentation Skills
| , , GPA:
Expected in 2013
Models for Innovative Thinking
| , , GPA:
Expected in 2013
Fierce Conversations
| , , GPA:
Expected in 2013Diploma | Graphic PackagingCarton College, , GPA:
Expected in 2013Microsoft Excel, Word, PowerPoint, One Note | , , GPA:
Expected in BS | ChemistryUniversity of Illinois, Champaign Urbana, ILGPA:
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School Attended
Carton College
University of Illinois
Job Titles Held:
Senior Quality Manager
Quality Manager
Quality Manager-ISO Representative
Degrees
<ul><li>RAC Certification In-progress</li><li>Disruption in Globalization</li></ul>
<ul><li>Keller and Heckman-Food Safety</li></ul>
<ul><li>Project Management Overview</li></ul>
<ul><li>Keller and Heckman-Food Packaging Law</li></ul>
<ul><li>Keller and Heckman-FDA Regulations</li></ul>
<ul><li>Henkel’s NA Food-Safe Packaging Forum 2013, 2017</li><li>Effective Presentation Skills</li></ul>
