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Quality, Regulatory Operations Proffesional/Manager

Location:
Hudson, OH
Posted:
February 26, 2016

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Resume:

Quality and Regulatory Professional

Leadership, integrity, tenacity, efficiency. A Six-Sigma Green Belt, a certified ISO Auditor, an experienced quality and regulatory professional with a scientific background and a proven track record of driving efficiency and continuous improvements in established groups, reducing costs and increasing quality, compliance and profitability of operations managed. Significant experience in the medical device industry and regulatory compliance with associated regulations with experience and accomplishments in:

● Staff Management and Development ● Pre-Market Approvals ● 21 CFR 820

● Continuous Improvement ● Effective Leadership ● ISO 13485-2003

● Implementation of policies and practices ● Effective Communication ● EU MDD

Professional Experience

Hudson Scientific Solutions, Hudson OH 2013 –

Small contracting firm in the area of regulatory compliance, quality system development and analysis. Fortune 500 clients in the pharmaceutical, medical device and chemical industries.

Independent Consultant

Providing services to include; system auditing, document creation, document review, risk analysis, system development, training and regulatory document filing and preparation.

Key Achievements:

Developed, implemented and maintained a system to comply with the conflict minerals reporting requirements of the 2012 Dodd Frank securities act. Resulting is the ability of the client to be able to report with their 2014 report 100% compliant.

Developed a quality system for a small startup life science company, enabling the organization to grow by having a consistent quality standard and organization. Resulting in a 35% increase in revenue by developing a larger customer base.

Successfully completed and UDI project for a client to improve inventory and traceability of finished, intermediate and raw materials. This was completed to the level needed to meet the US FDA Class III Medical device requirements

Successfully helped a client develop a system to be compliant with 21 CFR Part 820 of the Quality System Regulation (QSR) Resulting in an ability to pass a comprehensive third-party certification audit by a certifying body resulting in a certification report stating compliance that is filed with the FDA.

Successfully submitted two MDR reports to the FDA for a client resulting in a significant step in their completion of being compliant with the FDA requirements.

Completed numerous ISO 13485-2003 surveillance and recertification audits for a number of clients. Also completed a number of contract internal ISO 13485 audits to meet quality management standards.

M.P. Biomedicals, LLC, Solon, OH 2008- 2013

ISO certified global life science company specializing in biomedical research products, diagnostic reagents and crude grade pharmaceuticals. Over 300 employees globally and a $100M in yearly sales

Global Supply Chain Manager and Facility Operations

Managed the operation of the Solon warehouse and production facility, with special focus on: quality, compliance, safety and physical plant. Supported other global operations by ensuring they had the proper inventory on hand for their regional demand. Supervised: Incoming goods, Quality, Production, On-site Purchasing, Order Processing, Logistics, Shipping and Physical Plant Departments. Oversaw the processing of all returns and investigated complaints. Primary contact for the facility disaster response team.

Key Achievements:

Recognized as one of the top eight employees in the company by achievement and dedication, a member of the High Potential Leadership Group and Junior Executive Training Group. Attended and completed executive training and management courses and given two cost savings projects to manage and complete. For the first time projects resulted in a savings to the company of $125K.

Reduced (by 35%) customer complaints and returns from 1000 to 648 in one year through increased quality standards and checks and listening to customers feed back through various channels.

Instilled and improved the facilities safety programs resulting in no reportable injuries over a 2 year period. This was the longest since the facility began keeping records that there no reportable injuries.

Facilitated a shipping error rate reduction reducing the number of packages returned by over 25% from an average of 9 per day to a average of 2 per day out of 500.

Introduced and implemented a vendor managed inventory system for consumable supplies resulting in a 15% increase in cash flow by decreasing inventory on hand. This also decreased inventory lost by 40%.

Worked on and helped to write the SOPs and protocols for and completed the Biological License Application (BLA) to the FDA for HTLV Blot 2.4. Once this medical diagnostic kit is approved for confirmatory use in the US, it could result in $2.5M additional domestic sales

Reduced facility’s physical plant costs by $100K/ year through increase management and better use of resources available, this was the first time anyone had attempted to reduce physical plant costs

National Biochemical Corp., Twinsburg, OH August 2007- April 2008

A biochemical company specializing in unique products, academic laboratory and research products with 15 employees and annual sales of approximately $10M-$12M

Quality Control Manager

Managed the QC laboratory, received goods in, inspected and tested according to established SOPs to ensure quality and specification standards were met. Tested and approved all produced goods before being released for shipment. Supervised one QC tech and one QC chemist. Performed a variety of manual chemical tests for pH, metals, solubility and melting point along with FTIR, polarilimitry, UV and chromatograph tests as required.

R&D Chemist

Worked with senior R&D chemist to Prepare test batches and develop new products for sale. Oversaw test production runs in the pilot plant developed methods for testing troubleshot and experiment with products to improve quality and address customer concerns

Nestlé USA (Through Adecco Technical), Solon, OH May 2007- July 2007

A large food manufacture with a global operation leading the way in nutrition, health and wellness $10B per year in annual sales and 300K domestic employees

Microbiologist/ QA Inspector

Inspected incoming and outgoing goods specifically looking for foreign objects, tested for different forms of bacteria including E-coli, Salmonella, Staphylococcus aureus and Listeria monocytogenes. Ran chemical analysis test for lipids and proteins, prepared microbiological and molecular biology media, ran a Priorclave (PS/RSV/SH450) autoclave and did general laboratory up keep.

Education & Professional Development

West Virginia University Morgantown, WV

Master of Science, Genetics & Developmental Biology December 2006

Thesis Title: Induced Organ Regeneration via Re-Introduction of Harvested Stem Cells

Bachelor of Science, Biology December 2005

Minors: Chemistry, Communications and Statistics

Graduated Cum Laude

Bachelor of Arts, Philosophy (Ethics) May 2005

Technical Background

Six Sigma Green Belt

Quality Management Systems

ISO 9001 Auditing Trained and Certified Auditor

ISO 9001-2008/2015

ISO 13485-2003

American Society for Quality – Lean

Corrective Action Preventative

Medical Device Regulations

Root Cause Analysis

Good Manufacturing Processes

US FDA & EU EMA MDD

21 CFR 820

Team Development

Advanced computer skills in warehouse, customer management and statistical software

Advanced technical writing experience including SOPs and SDSs



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