Quality Management

Patrick Eckrich

*** *. *********** *****, *******, Ohio 44805 Cell 419-***-**** acu5ix@r.postjobfree.com

CAREER PROFILE

Management professional with eighteen years of manufacturing experience in the medical device, solution, consumer products and aerospace industries. Proven results in management and training of personnel, quality data collection and analysis, and compliance to corporate policies and regulatory requirements. Areas of expertise include:

Personnel Management Audits and Assessments

Product Development Quality System maintenance and management

cGMP and regulatory compliance Cost Reduction and Continuous Improvement

SOPs, specifications and documentation Departmental Budgets

Validations Product development

Investigations CAPA

ACCOMPLISHMENTS

Completed projects for the new Aerospace business worth 4MM

Implemented an ISO 9000 and AS 9100 systems

Implemented Lean principles

Maintained a reject rate of less than 0.5% and 0% product recall

Set up manufacturing and product specifications for contract manufacturers

New product development - from concept through production

Changes to current products in the marketplace

Tested and approved alternate materials for cost reductions

Supplier scorecard system to improve supply chain efficiency

TRAINING

Cause Analysis

FMEA

ISO 9000 and AS 9100

Chemical Engineering for Chemist - ACS

Regular training on cGMP, cGLP, FDA 21 CFR part 11, 210, 211, 820

Statistical Design of Experiments

Statistical Control of Manufacturing Processes

Experience with use of various laboratory equipment, including HPLC, GC, FTIR, AA, UV-Vis, Karl Fisher Titrator, EDXRF, others

Microbiological Techniques

Computer skills include Windows Word, Excel, PowerPoint, Visio, Access, Outlook, Applied Statistics, Expandable, Trackwise, SmartCAPA, SAP, AS400, others

EDUCATION

Masters of Business Administration, Executive Management, Ashland University – Ashland, Ohio

Bachelor of Science, Combined - Chemistry and Biology, Youngstown State University – Youngstown, Ohio

PROFESSIONAL EXPERIENCE

AMERICARB, INC. Ashland, Ohio 2012 - Present

VP of Operations

VP of New Product Development and Quality Systems

Quality Director

Manage over 125 employees

Oversee all aspects of operations for 3 plants

Management Review

Ran the Product Development and Project Meetings for the Corporation

Develop and monitor the KPI’s for the plants

Implement the electronic quality module

Interact with external auditors to demonstrate compliance and product safety and efficacy.

Recruit, retain, train, develop, manage and lead all plant personnel.

Lead the plant management to achieve cost, quality, service and innovation initiatives.

Initiate and implement appropriate corrective and preventive actions related to product or process quality.

Provide quality plans for engineering projects including the development and implementation of quality specifications and methods.

Manage departmental spending to the established budget and lead departmental financial initiatives to effectively utilize resources.

BARBASOL, LLC. Ashland, Ohio 2010 - 2012

Quality Manager

Oversee all aspects of the quality system including executing periodic Management Reviews.

Interact with external auditors to demonstrate compliance and product safety and efficacy.

Recruit, retain, train, develop, manage and lead all plant quality personnel.

Participate as a member of plant operations management to achieve cost, quality, service and innovation initiatives.

Act and report on all key quality indicators.

Initiate and implement appropriate corrective and preventive actions related to product or process quality.

Provide quality plans for engineering projects including the development and implementation of quality specifications and methods.

Manage departmental spending to the established budget and lead departmental financial initiatives to effectively utilize resources.

HOSPIRA, INC. Clayton, North Carolina 2007-2010

Incoming Quality Supervisor

Work with Materials Management to ensure production has the required materials to meet the schedule

Schedule the sampling, testing and release of the raw materials and commodities as they are received

Ensure Chemistry testing in the raw drug lab is completed on time

Review all Raw Material Chemistry Testing and Incoming Quality records

Review materials that are returned for retest

Manage the Controlled Component program

Approve all changes to Controlled Components

Represent the Incoming Quality group in all audits

Handle the laboratory investigation reports (LIR’S) for the Raw Material Chemistry and exception reports (ER’s) for Incoming Quality

Attend meetings with vendors and other departments to resolve CAPA issues

Complete projects as assigned such as Skip Attribute Program, Approved Supplier List and Chemistry Council

Chemistry Quality Supervisor (2007-2008)

Scheduled and Supervised all aspects of the raw drug and final product chemistry testing

Managed non-exempt employees through Lab Supervision

Update SOP’s to match Hospira corporate policies and procedures

Review and sign for all chemistry testing

Assist with investigations regarding customer complaints

Perform Laboratory investigations and enter them into the SmartCAPA system

Worked closely with materials Management prioritizing on-test materials

NORTH CENTRAL STATE COLLEGE, Mansfield, Ohio 2006 – 2007

Adjunct Instructor, Business Management

ABBOTT LABORATORIES, Ashland, Ohio 1998-2007

Quality Laboratory Supervisor (2002-2007)

Supervised, trained and counseled 16 quality personnel in accordance with cGMP, Quality Systems, collective bargaining agreements, and corporate policies and procedures

Maintained departmental budgets for materials, labor, capital expenditures, etc.

Developed and maintained laboratory quality specifications and operating procedures

Performed quality auditing of manufacturing operations and batch record documentation

Chaired meetings and led investigations regarding customer complaints, audit observations, disposition of nonconforming materials, and development of corrective action/ preventive action recommendations

Sr. Quality Laboratory Technician (2001-2002)

Performed microbiological and environmental testing and monitoring of medical parts, clean rooms and utilities

Conducted routine supplier quality audits

Supervised Quality Laboratory on 2nd shift and ensured timely completion of all testing of incoming materials and finished goods

Performed duties of Quality Laboratory Technician

Trained seven new lab technicians

Promoted to Laboratory Quality Supervisor

Quality Laboratory Technician (1998-2001)

Sampled, tested, dispositioned and released incoming raw materials and manufactured finished goods

Created and revised departmental SOPs, Standard Test Methods, and other official laboratory documentation

Conducted and documented laboratory investigations, nonconformance reports, and CAPA activities

Promoted to Sr. Quality Laboratory Technician

References

Matt Reineke

President

Americarb, Inc.

Ashland, Ohio

Phone: 330-***-****

Lee Reineke

Chairman of the Board

Americarb, Inc.

Ashland, Ohio

Phone: 216-***-****

Eugene Cabonor

CFO

Americarb, Inc.

Ashland, Ohio

Phone: 847-***-****

Additional references available upon request

Contact this candidate