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Quality Engineer

Location:
Scottsburg, IN
Salary:
100000
Posted:
February 09, 2021

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Resume:

Stephen M. Schafer

**** **** ******

Scottsburg, Indiana 47170 Cell: 812-***-****

CAREER OBJECTIVE

Seeking a full time position in the chemical industry that would require the extensive use of quantitative, qualitative, and instrumental analyses, or a full time position in Management that would require the use of my supervisory experience and training.

EDUCATION

University of Evansville, Evansville, Indiana.

Graduated May 6th 1995 with a Bachelor of Science Degree in Chemistry.

SUMMARY OF QUALIFICATIONS

Coordinated, scheduled, and documented all outsourced certified Safety Training - Adult First Aid with CPR and AED.

Organized, conducted, and documented all Monthly Safety Meetings according to the set 2007 Monthly Safety Meeting schedule.

Performed and documented the Monthly Safety Audits / Inspections for each of the three ( 3 ) Plant areas.

Performed and documented the Bi-Weekly Tank Inspections for each of the three ( 3 ) Plant areas.

Trained for the position of Assistant Plant Manager.

Worked with Honeywell and Foxboro systems to establish automatic controls for pH, temperature, and flow within the Organic Pigment production processes.

Served as a Technical Liaison to Engineering Department to automate Organic Pigment manufacturing processes using Allen-Bradley PLC’s running Wonderware In-Batch, Wonderware In-Touch, and Factory Link Softtware.

Supervised 3 - 4 salaried Quality Assurance Lab Technicians.

Trained and worked as a Fill-In Production Supervisor on an as needed basis for four ( 4 ) years.

Trained on SPC and SPQC quality tracking systems.

Served as member of Engelhard Corporation’s site HazMat Team.

Performed and documented Pilot Plant Bldg. 3 Monthly Safety Audit.

Performed and documented Weekly Hazardous Waste Storage Inspections / Audits for three ( 3 ) different Plant areas.

Served as member of Engelhard Corporation’s site Cost Reduction Team that contributed over $500,000 annually to site profits by maximizing equipment capacity utilization and increasing production quality, thus reducing Off-Spec production by > 60% over a two-year period.

PROFESSIONAL EXPERIENCE

Multi-Color Corporation; Scottsburg, Indiana. ( December 2017 – Present )

Quality Engineer.

Job Summary: Lead the plant product safety program to ensure certifications are obtained and maintained as determined by the company. Conduct routine audits of the Press, Finishing, and other departments that are now or may become part of the plant wide audit process. Analyze data using Microsoft Excel and/or Minitab to look for trends in process data. Verify that new products follow qualification protocol. Validate graphics and color targets for new products. Track process trials, ensuring that samples are taken and tested as appropriate and according to the trial plan. Lead project teams that will improve the process. Work with operators to understand cause and effect of changes in process conditions. Ensure that all Process Plan of Control sheets are being properly completed, are in the proper format, and are legible. Record all exceptions on the auditing forms and report them to the Production Manager. Facilitate corrective action plan development in response to internal audits, QDR analyses, and customer complaints. Conduct supplier audits. Develop and maintain FMEA’s and control plans. Maintain plant wide calibration program, conducting measurement system analyses as needed to ensure effectiveness of measurement systems. Cover for Quality Manager, Quality Administrator, Lab Technician, and Process Technicians as needed. Conduct lab testing as needed to ensure customer COA data requirements are met. Maintain a safe working environment and work in a safe manner consistent with company policies and common safety practices. Maintain a working knowledge of applicable Procedures, Work Instructions, and Process Plan of Control for all departments involved in the Internal Audit Process. Attend Daily Scheduling Meeting. Attend Weekly Waste Team Meeting. Complete all Product Specifications in Alpha V. Update all Specifications removing all/any obsolete items. Coke REFPET bottle decoration with production labels as needed for 3.5% NaOH Testing. 3.5% NaOH Solution preparation and concentration/purity analysis by titration. Meet Safety Participation Goal. Complete all Monthly Safety Trainings. Safety Captain.

Schwarz Pharma/Kremers Urban Pharmaceuticals/UCB Group/Lannett Company Inc; Seymour, Indiana. ( June 2008 – December 2017 )

Raw Materials Chemist – Team Lead ( June 2015 – December 2017 )

Job Summary: Coordinate the daily activities of team members, including daily scheduling and tracking, by leading and organizing team members to provide timely and efficient testing, provide testing completion dates to the QC supervisor and other internal customers, and promptly communicate any schedule changes, coordinate and perform accurate and timely analysis of raw materials, packaging materials (i.e. incoming, retest) and cleaning validation samples according to current analytical procedures, SOPs and laboratory guidelines, ensure that all pertinent information regarding the team is entered into the appropriate databases for tracking and capacity modeling purposes, ensure proper cross-training of team members, coordinate and perform analytical method transfers with the Analytical Development (AD)/Support groups to QC, coordinate and perform laboratory equipment calibration and preventative maintenance, coordinate and communicate with the other groups regarding cleaning validation swabbing and testing, work with QC management to provide well-written, accurate and timely reports regarding laboratory investigations for the team, assist in the evaluation and improvement of departmental SOPs and testing procedures, perform all work using appropriate safety measures, document all laboratory testing and maintain accurate and legible notebooks and records, peer review of data, reports and notebooks, provide input to QC management regarding goals and performance evaluations of team members, and assist in special projects or other tasks as deemed necessary based on individual's qualifications, business needs and QC management’s discretion.

Pharmaceutical Technology / Technical Services Specialist. ( June 2013 – June 2015 )

Job Summary: Primary responsibilities include providing Technical Support for Marketed Products to the QA and Manufacturing Departments, providing Production troubleshooting and Manufacturing assistance, participating in or leading problem solving for Formulation, Equipment, and Processes, initiating and carrying out Investigations and Corrective Actions/Preventive Actions ( CAPAs ), performing Risk Assessments and generate Product Impact Evaluations for Manufacturing Incident Reports, writing and reviewing Investigation/Technical Reports, ensuring the collection of Process Data and thorough Scientific Data Review in order to substantiate the conclusions and recommendations in Investigation/Technical Reports, reviewing GMP Documents ( MBRs, SOPs, RM Specification, and Protocols ) and generating Change Controls, performing scale-up/scale-down and Process Optimization of Marketed Products, generating Manufacturing Batch Records ( MBRs ), Protocols, Sampling/Testing Plans for Experimental Batches, executing Experimental Batches directing Operators and Technicians in support of this, assisting Validation Department in execution and observation of Process Validation Batches, providing Technical Assistance to Validation Team in identifying Critical Process Parameters ( CPPs ), and member of Site Safety Committee.

Analytical Development Support Chemist. ( November 2008 – June 2013 )

Job Summary: Primary responsibilities included the analysis and laboratory support for all Non-Marketed Products of SPMI. This included the analysis of Approved Products to meet all Post-Approval Stability Commitments according to current Analytical Procedures, SOP’s, and Laboratory Guidelines. This also included the support of Manufacturing in the analysis of Process Verification and Validation, In-Process, and Finished Product Samples according to current Analytical Procedures, SOP’s, and Laboratory Guidelines. Essential Functions: Performed accurate and timely analysis of Pre-Clinical, Process Verification and Validation, In-Process, Finish Product Samples, and Post-Approval Stability Samples according to current Analytical Procedures, SOP’s, and Laboratory Guidelines, Analytical Method Transfers with the Analytical Development Group, Peer Review of Data, Reports, and Notebooks, Laboratory Equipment Calibrations and Preventative Maintenance, Special Projects or other tasks as deemed necessary based on Business Needs and Supervisor’s/Manager’s discretion, all work using the appropriate Safety Measures and following the Chemical Hygiene Plan, documented all Laboratory Testing and maintained accurate and legible Notebooks and Records, provided well-written, accurate, and timely Reports regarding Laboratory Investigations, assisted in maintaining Laboratory Equipment and Facilities, and in the evaluation and improvement of Analytical Procedures, SOP’s, and Laboratory Guidelines, and member of the QC Safety & CIP ( Continuous Improvement Process ) Committees.

Buzzi Unicem USA; Greencastle, Indiana. ( April 2008 – October 2008 )

Quality Engineer.

Responsibilities included supporting the Concrete Laboratory and the various Cement Plants with the Chemical and Physical Testing of Cement, and the Making and Testing of Concrete Specimens, supporting the Manufacture and Testing of Specialty Cement Products at the various Plants, working with all Electronic Quality Testing Equipment installed at the various Plants and Concrete Lab, helping with New Product Research and Testing, operating Fluorescence, Diffraction, and Emissive X-Ray Testing Equipment installed at the various Plants, maintaining neat and orderly Testing Data, relating Reports and supporting Documents to the appropriate personnel, becoming available to fill-in at the various Plants as Quality Manager, supporting Technical Services, as needed, with Customer visits and Sample Handling, Testing, and Reporting.

Multi-Color Corporation ( Manpower ); Scottsburg, Indiana. ( January 2008 – April 2008 )

Product Development Coordinator.

Responsibilities included managing assigned Projects within the Decorating Solutions Division Product Development function, development, qualification and commercialization of approved Projects to ensure fit meeting Customer demands, Production Feasibility, Cost/Benefit, and Safety, assuring the Safety and protection of Human Resources of the Research and Development Team, creating a Customer-Focused culture for Decorating Solutions Division by enhancing overall Customer satisfaction through efficient Product Development and efficient Technical Service efforts, creating a culture of relentless pursuit of Continuous Improvement, including contributing to and supporting Operations, New Business Development, and the centralized Purchasing Objectives as well as Six Sigma and Lean Manufacturing, Customer Service efforts and contributing to Company Cross-Functional Teams to achieve the overall

effectiveness of Customer relationships, including Customer visits and interaction as needed, qualifying and managing Suppliers, maintaining and improving personal Scientific knowledge and skills, obtaining Market Intelligence for sharing within Multi-Color, staying abreast of New Technologies, Products, and Processes pertaining to the Industry, assuring compliance with Government regulations, modeling the Corporate Values and Principles, and instilling a high performance, people-driven culture, providing high expectations, and high support.

Chryso Inc.; Charlestown, Indiana. ( June 2003 – November 2007 )

Quality Control – Production Technician.

Responsibilities included overall operation(s) of the Quality Control Laboratory – formulating, implementing, and maintenance of all Cement Grinding Aid and Concrete Admixture batch orders / manufacturing procedures within the specified guidelines, issuing Cement Grinding Aid and Concrete Admixture batch orders / manufacturing procedures to Production on a daily basis, assisting in the development and documentation of all current / new QC test methods / procedures for all Cement Grinding Aids, Concrete Admixtures, and their respective raw materials, preparing and QC testing all current / new Cement Grinding Aid and Concrete Admixture Standards, establishing QC specifications for all current / new Cement Grinding Aids and Concrete Admixtures from the aforementioned prepared and QC tested Cement Grinding Aid and Concrete Admixture Standards, authoring, implementing, issuing, and maintenance of all Cement Grinding Aid and Concrete Admixture COA’s, authoring, implementing, issuing, and maintenance of all Cement Grinding Aid and Concrete

Admixture Product labels, initial Cement Grinding Aid and Concrete Admixture production quality, deriving, investigating, & implementing Cement

Grinding Aid & Concrete Admixture production process and safety improvements, establishing QC specifications for all current / new Cement Grinding Aid and Concrete Admixture raw materials, QC testing of all current / new Cement Grinding Aid and Concrete Admixture raw materials, and QC testing of all finished Cement Grinding Aids and Concrete Admixtures. Such tests included APHA color, moisture ( % H2O ) determination by Karl Fischer ( EMD AQUASTAR AQV33 KF Titrator & EMD AQUASTAR V1B KF Titrator ), density and specific gravity ( Anton Paar DMA 38 Density / SG / Concentration Meter ), solids content ( Barnstead Type FB1300 Muffle Furnace & Precision Laboratory Ovens 130DM & Economy ), pH ( Mettler Toledo 7 Easy pH Meter & VWR sympHony Portable pH Meter ), gas chromatography ( Shimadzu GC-14A w / Shimadzu AOC-20 Auto Injector / Auto Sampler ), titrations ( Amine Equivalent Weight [ AEW ] Acid / Base and Chloride [ Cl- ] Determination – Metrohm 719S Titrino Auto Titrator ), and loss on ignition ( LOI – Barnstead Type FB1300 Muffle Furnace ). Additional responsibilities included calibration / preventative maintenance of / on all QC Lab equipment / instrumentation, ordering all necessary consumable materials ( beakers, bottles, boxes, chemicals, glass vials, syringes, etc. ) in order to keep the QC Lab operating cost-effectively and efficiently, and working in production ( loading / unloading trucks and railcars, manufacturing Cement Grinding Aid and Concrete Admixture finished products, and acquiring finished product samples for Customers and Sales Team ) on an as needed basis.

Holm Industries Incorporated; Scottsburg, Indiana. ( September 2002 – February 2003 )

R & D Chemist.

Responsibilities included development projects and feasibility studies of new flexible and rigid PVC compounds, laboratory testing and experimental work as components of R & D projects, data analysis, conducting production trials for new compounds or raw materials and reporting the results, obtaining NSF ( National Sanitation Foundation ) and UL ( Underwriters Laboratory ) approval for selected flexible and rigid PVC compounds, & internal ISO Quality Audits.

Engelhard Corporation; Louisville, Kentucky. ( November 1996 – September 2002 )

Organic Pigment Plant Support Associate Chemist. ( September 1997 – September 2002 )

Responsibilities included writing, implementing, and maintenance of all Organic Pigment manufacturing procedures within the guidelines of ISO 9000 Quality Management System, issuing Organic Pigment manufacturing procedures to Production on a daily basis, adjusting Organic Pigment manufacturing processes in order to produce the desired color values needed by the Quality Control Lab for blending purposes on a daily basis, monitoring Organic Pigment manufacturing processes on an as needed basis, initial Organic Pigment production quality, performing Organic Pigment laboratory and Pilot Plant reactions / strikes to test for the quality of raw materials and the effects of process variables such as agitation, flow rate, pH, and temperature have on LAB color values, and working with all levels of management and quality teams to maintain ISO 9002 Quality Management System registration using accredited ISO 9000 registrar.

Quality Control Lead Lab Technician. ( November 1996 - September 1997 )

Responsibilities included performing wet and dry pigment blending, writing-up, and issuing blend slips to Production, running assorted tests on pigment at various stages of production, communicating these test results to the Production Supervisor and / or Operator with any necessary process changes, and analyzing / testing raw materials to determine quality. Such tests included LAB color values, conductivity, grind, oil absorption, particle size, solids, titrations, HPLC, and X-Ray diffraction. Worked with Production Department to improve production cycle time by reducing testing time through automation and process improvement. Supervised 2 - 3 salaried Quality Control Lab Technicians.

Flint Ink Corporation; New Albany, Indiana. ( January 1996 - September 1996 )

Quality Assurance Lab Technician.

Responsibilities included running assorted tests on ink at various stages of production, adjusting batches of ink in process, checking finished ink for shipment, checking truck samples, and doing the appropriate paperwork that accompanied each shipment of ink. Such tests included color, viscosity, gas chromatography, and VOC.

COMPUTER SKILLS

Lotus 1234W, Lotus SmartSuite, Quattro Pro, Lotus Notes, Microsoft Windows 3.1, Microsoft Windows 95, Microsoft Windows NT, Microsoft Windows XP, Microsoft Windows Vista, Microsoft Office 97, Microsoft Office 2003, Microsoft Office 2010, Microsoft Outlook, Adobe Reader, Marcam’s Protean Enterprise Management System, SAP, AS400 LIMMS Systems, LabVantage, Chromeleon 6.8 and Chromeleon 7 Chromatography Data Systems, TrackWise Enterprise Quality Management Software (EQMS), Wonderware In-Batch, Wonderware In-Touch, Factory Link, QPulse, Radius, Alpha V, and Minitab



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