James Stainsby
Noblesville,IN
Summary
Motivated to exceed expectations and contribute to customer satisfaction with high-quality work. Proficient in troubleshooting and developing solutions to a wide range of instrumentation issues. Advanced skills in Metrology.
Knowledgeable Calibration Technician skilled at evaluating, repairing and maintaining a wide range of equipment. Detail-oriented and hardworking with understanding of applicable codes, environmental standards and safety requirements. Excellent communication and planning abilities. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Calibration Technician
Roche Diagnostics
- I provide timely and accurate calibration support to manufacturing, packaging, quality, and other supporting departments where GMP instruments are used
- Utilizing cGDP process and controls I Set-up standards and special purpose laboratory equipment to test, evaluate, and calibrate instruments, including researching instrument specification
- I complete all calibrations in compliance with applicable standard operating procedures or follow manufacture’s manual/procedures for calibration when applicable
- I am responsible for instrument recertification with outside standard laboratories, which includes performing incoming inspections and documentation reviews on these instruments
- I participate in continuous improvement functions (Lean initiatives), which increase efficiency, solve problems, and improve quality.
Senior Metrology Technologist
Global Insight. (contracted to Vertex Corp formerly Raytheon, now V2X)
2022.08 - 2023.01
- Responsible for the repair, recall and calibration of all test equipment within the organization
- Restructured gage laboratory utilizing 6 sigma Lean practices
- Updated documentation and procedures in excess of 20 years to current practices
- Conducted gauge R&R’s, MSA’s as well as calculating uncertainty budgets to ISO17025 compliance
- Conducted GAP analysis from Z540.3 to ISO17025 to facilitate compliance
- Utilized and converted test equipment from 1960’s to current test equipment
- I..E
- Proving rings to force transducers.
Senior Facilities Technician
Incog Biopharma
2021.01 - 2022.06
- Responsible for the repair, recall and calibration of all test equipment within the organization
- Implemented calibration protocols of all instrumentation within the Facility
- Implemented BM RAM CMMS software and developed all Work Instructions and SOP’s for all instrumentation
- Maintained and troubleshot facility equipment, identifying and repairing exhaust and heating equipment while utilizing cGDP and CGMP practices
- Retained and observed Vendors to perform calibrations on Laboratory equipment including HPLC, TOC analyzers
- Installed and conducted acceptance inspection of all test equipment to facilitate new production line as well as IQ/ PQ requirements.
Senior Facilities Technician
Curium US LLC
2021.07 - 2021.12
- Responsible for the repair, recall and calibration of all test equipment within the organization
- Implemented calibration protocols of all instrumentation within the Facility
- Maintained and troubleshot facility equipment, identifying and repairing exhaust and heating equipment while utilizing cGDP and CGMP practices
- Retained and observed Vendors to perform calibrations on Laboratory equipment including HPLC, TOC analyzers
- Installed and conducted acceptance inspection of all test equipment to facilitate new production line as well as IQ/ PQ requirements.
Metrologist
Dorma Kaba Corp.
2011.07 - 2021.07
- Implemented ISO9000 processes for calibration and established Quality processes and documentation
- Responsible for the repair, recall and calibration of all test equipment within the organization
- This included all electronic, and mechanical equipment
- Utilizing hand held instruments as well as bench meters, oscilloscopes and other test instruments
- Implemented Calibration Maintenance Management System and fully integrated with legacy system
- Participate in first article inspections, I utilize statistical methods, GR&R, capability analysis to determine predictive and preventative measures
- I participate in Six Sigma events including Kaizen submissions and developmental processes
- I participated in developing production processes and machine operations working with machinists and plant personnel
- I participated in performing Quality Audits, as well has facilitate Quality Corrective actions review board
- Performed lean Six Sigma inspections and participated in Kaizen events
- I conduct sampling plans for both attribute and variable data for dimensional gaging.
Group Leader/Calibration Specialist
Farsenius Kabi / APP Pharmaceutical / Abraxis Bioscience
2008.11 - 2011.07
- Responsible for all aspects of the instrumentation within the plant; including calibration and repair of RTD’s, pressure transducers, Thermocouple’s, Water for Injection systems and HVAC instrumentation
- I also maintain all PLC systems and integrated processes
- Formally trained in cGDP and cGMP
- Answered FDA audits, CAPA’s and IQ/OQ/PQ’s.
Education
Bachelors of Arts - Management
Walsh College of Business Management and Accountancy
06.2001
Associates Degree Business Administration -
Oakland Community College
06.1998
Skills
- Tolerance calculations
- Electrical Troubleshooting
- Quality Control Procedures
- Test equipment operation
- Precision measurement
- Root Cause Analysis
- Regulatory Compliance
- Instrument Calibration
Awards Community Service
- Advanced PMEL Trained, US Air Force LOWRY AFB, as well as US NAVY Calibration Maintenance program.
- Certified Calibration Technician through American Society for Quality, (ASQ)
- Six Sigma trained, PPAP, MSA, ISO900/QS9000 in house auditor.
- Retired after 20 years from the Navy.
Certification
- CCT - Calibration Technician
Timeline
Senior Metrology Technologist
Global Insight. (contracted to Vertex Corp formerly Raytheon, now V2X)
2022.08 - 2023.01
Senior Facilities Technician
Curium US LLC
2021.07 - 2021.12
Senior Facilities Technician
Incog Biopharma
2021.01 - 2022.06
Metrologist
Dorma Kaba Corp.
2011.07 - 2021.07
Group Leader/Calibration Specialist
Farsenius Kabi / APP Pharmaceutical / Abraxis Bioscience
2008.11 - 2011.07
Senior Calibration Technician
Roche Diagnostics
Bachelors of Arts - Management
Walsh College of Business Management and Accountancy
Associates Degree Business Administration -
Oakland Community College
- CCT - Calibration Technician
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