Quality Assurance Control

Jurij A. Silecky

**** ******** ***** • Holland, Ohio 43528

Phone: 419-***-**** Email: *****@***.***

• QUALITY ASSURANCE • LABORATORY MANAGEMENT PROFESSIONAL • QUALITY CONTROL

• GMP • QUALITY ENGINEERING • INORGANIC CHEMISTRY • ISO 17025

Management professional dedicated to technical excellence, quality assurance and quality control. Strong technical foundation coupled with

extensive industrial, pharmaceutical, medical device and consumer product testing lab experience. Relied upon to manage crises, improve

struggling processes, and perform fundamental root-cause-analysis. Management experience encompasses Operations Planning, P&L, Quality

Assurance, Lab Management, Continuous Improvement, Safety, Supervision, Lab Design Planning and Quality Engineering. Experienced in

managing 24/7 laboratory operations with 62 direct and indirect staff members. Specialist in elemental and spectrochemical analysis.

PROFESSIONAL EXPERIENCE

Vice President, Technical Services July, 2013 – Present

Avomeen Analytical Services, Ann Arbor, MI

(Pharmaceutical, Industrial Formulation and Material Testing Laboratory)

• Operational and technical responsibility for laboratory sectors

• Manage Technical Directors and Senior Scientists

• Oversee implementation of ISO 17025 accreditation

• FDA/GMP audit lead

• Create project proposals and manage new client relationships

• Implement continuous improvement and safety strategies

Director of Operations/Quality Systems Manager (Interim Position) Jan, 2013 – Jul, 2013

ICS Laboratories, Inc., Brunswick, OH

(ISO 17025 accredited Personal Protective and Athletic Equipment Testing Laboratory)

• Maintain complete operational and technical responsibility for the laboratory

• Manage corporate ISO 17025 quality system and expand scope of accreditation

• Head the quality assurance function

• Train new quality assurance staff

• Manage daily business activities, operations and business development planning, P&L and facilities management

Director, Chemistry Operations 2010 - 2012

CONSUMER TESTING LABORATORIES, Bentonville, AR

(ISO 17025 accredited Global Consumer Product Testing Laboratory)

• Maintained complete technical, quality and operational responsibility for all chemical testing

• Managed daily business activities of a $10M+ department including strategic and operations planning, purchasing/inventory control, P&L, budgeting facilities

management, safety and employee relations

• Supervised a staff of 62 with 3 managers and 5 supervisors in a 24/7 production environment

• Increased testing capacity by 50% with only 24% staff augmentation while reducing turnaround times by 33%

• 100% growth in the number of tests on the labs scope of accreditation in one year’s time

• 500 to 1000 test per day work load with most having 24 to 48 hour turn time

• Developed training programs to increase knowledge of chemicals, processes and regulations

• Aligned lab practices between worldwide locations for consistency of testing and reporting of results

• Reduced supply costs by 30% through supplier contract pricing management

• Implemented new testing methodologies from many international agencies such as CPSC, FDA (CFR), USP, EPA, IEC, DIN, NIOSH and ASTM

• Specialized in inorganic elemental analysis using ICP and ICP/MS

Manager, Laboratory Administrative Services and Business Development 2005– 2010

WEST PHARMACEUTICAL SERVICES (formerly MONARCH ANALYTICAL LABORATORIES), Maumee, Ohio

(ISO 17025 accredited GMP laboratory serving the pharmaceutical, industrial and consumer product industries)

• Acted as Subject Matter Expert for testing programs and client relations

• Created and approved DQ, IQ, OQ and PQ documents

• Administered sample project management and lifecycles

• Authored and approved E/L study and method development/validation protocols

• Managed a variety of functions including Administrative, Financial and QA processes with 3 direct administrative reports and 27 indirect staff

• Created and implemented structured business plan for materials testing division

• Acted as Subject Matter Expert for testing programs and client relations

• Proposed, authored and approved E/L study and method development/validation protocols

Inorganic/Elemental Laboratory Manager 1995 – 2005

MONARCH ANALYTICAL LABORATORIES, Maumee, Ohio

(ISO accredited GMP laboratory serving the pharmaceutical, industrial and consumer product industries)

• Supervised all aspects of the wet chemical and instrumental laboratories’ daily operations with 8 direct reports (2 leaders and 6 chemists)

• Increased revenue 300% in a three year time span by impeccable customer relations

• Improved turn-around times by 100% through use of lean initiatives and continuous improvement strategies

• Helped implement ISO 17025 laboratory accreditation and convert laboratory to a GMP facility

JURIJ A. SILECKY PAGE 2

SUMMARY OF QUALIFICATIONS

QUALITY / COMPLIANCE

ASQ Certified Quality Engineer

Created and administered ISO registered/accredited and GMP mandated facilities

Experience with FDA and ISO audits in GMP facilities

Created and maintained SOPs which conform to internal policies/procedures and regulatory expectations

Proficient in auditing and composing audit responses

Strong root cause determination, OOS and CAPA skills

Continuous improvement, Lean Manufacturing and Six Sigma

MANAGEMENT/OPERATIONS

Managed daily business activities of a $10M+ location including Strategic and Operations Planning, Purchasing/Inventory Control, P&L

Management, Accounts Receivable/Payable and Human Resources

Led/managed multiple departments and disciplines

Proven track record of streamlining workflow and creating a team environment to increase productivity

Experienced in analyzing and streamlining systems/operations that increased productivity, quality and efficiency using LEAN manufacturing theory

Excellent leadership, management, oral/written communication, interpersonal, intuitive, and analysis skills

Thrive in both independent and collaborative work environments

Adopts a systematic approach to problem solving, effectively analyzes results, and implements solutions

TECHNICAL SKILLS

Well versed in most analytical techniques and instrumentation including AA, ICP, ICPMS, GCMS, HPLC-MS, FTIR, UV-VIS, IC and XRF

Expert in Inorganic Spectrochemical analysis

Written many Quality Assurance Documents (SOP and WI) for GMP and ISO environments

Managed safety team and handled regulatory/compliance issues

Able to rapidly achieve organizational integration, easily assimilate job requirements and aggressively employ new methodologies

EPA, ASTM, USP, FDA (CFR), NIOSH, AOAC, DIN, ISO and JP method experience

Developed and validated methods according to ICH and FDA guidelines

Implemented and involved with Lean Manufacturing Theories

Well versed in quality and quality control processes

Composed proposals and technical documents/protocols

Hazardous Chemicals Management and Testing

Great familiarity with CPSIA, FDA, Health Canada, TPCH, Prop 65, EPA regulations and requirements

Reviewed/edited/approved confidentiality and service agreements

Formalized financial agreements

Strong LIMS background

EDUCATION / PROFESSIONAL DEVELOPMENT

Bachelor’s Degree in Chemistry and Biology

University of Toledo - Toledo, OH

• Attended company sponsored training in: Sandler Sales Training, Multiple SAP Module Training, Annual GMP Training, Trackwise ™ Software

Training, Lean Manufacturing and SAP Software Training

• Self-Study in HACCP, Quality Engineering and Quality Management

PROFESSIONAL AFFILIATIONS

• American Society for Quality – Certified Quality Engineer

• AOAC International – Association of Analytical Communities

• Society of Glass and Ceramic Decorators - Invited Speaker for multiple annual conventions

LinkedIn Profile: http://www.linkedin.com/in/jurijsilecky/

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