Quality Assurance Analyst

Jason Boyer *** Moore Road ~ Rochester, NY *****

585-***-**** ~ ***********@*****.***

Experience

Ortho-Clinical Diagnostics, A Johnson & Johnson Company - Rochester, NY

**/** – Present Quality Assurance Analyst

• Performs, evaluates, and reviews quality statistical analysis (using LIMS/Excel/Minitab) required for accuracy release

testing of product coating lots for use with VITROS Clinical Chemistry Systems

• Determines if new product lots meet release criteria vs. established and in-date product generations; assigns new

math/limits to lots if performance does not meet specifications

• Generates release documentation and SAP transactions upon confirmation of product acceptability

• Authors test designs and performs master data updates/QM entries (LIMS)

• Assumes ownership of select product chemistries, orders product samples, and schedules lab testing

• Creates, reviews, and audits Data Release Versions/Assay Data Disks (using LIMS) to effectively update

product specifications on VITROS Clinical Chemistry Systems in the field

• Generates and distributes product Certificates of Analysis to customers worldwide

• Responsible for training employees on laboratory systems/ data analysis in accordance with modules and SOPs

• Renumbers production coatings for inventory purposes (SAP) and oversees pilot process for testing and release to countries

with specification requirements that differ from the rest of the world

• Troubleshoots testing issues and documents non-conformances/CAPA plans (QERTS/Trackwise)

• Responds to customer complaints and investigates field issues; maintains product vigilance

• Proficient in change control practices (OTIS author); script testing and validation experience

• Process Excellence/Six Sigma Green Belt training complete; certification project underway

• Working knowledge of GMP, GLP, and FDA regulations

• First Aid and CPR/AED certified emergency medical response volunteer for facility

Ortho-Clinical Diagnostics, A Johnson & Johnson Company - Rochester, NY

05/05 03/06 Quality Assurance Technician

• Performs clinical laboratory testing on microslide product coating lots for use with VITROS Clinical Chemistry

Systems (VITROS 250/350, 950, 5,1 FS, DT-60, and DTSC systems) and in accordance to SOPs

• Calibrates instrumentation and confirms systems pass control limits using manufactured calibrator kits and

performance verifiers; tests patient specimens (blood, urine, CSF, linearity) in accordance to design

• Performs daily and weekly maintenance on systems; troubleshoots testing/instrumentation issues

• Monitors and maintains freezer inventory of testing fluids/microslide lots for multiple groups

Eastman Kodak - Rochester, NY

11/03 – 5/05 Quality Assurance Technician

• Conducts quality analysis of film components (dyes, dispersions, etc) used in film production

• Performs laboratory testing though the use of UV/Vis spectrophotometers, DMA/DWT (density), near

infrared (NIR) technologies, titrations, microwave units, viscometers, and microscopes

• Communicates results to solution makers to ensure necessary product concentration and adjustments

PMP Fermentation Products, Inc. - Peoria, IL

12/96 – 11/03 Production Operator

• Identifies and troubleshoots production process issues

• Conducts laboratory analysis using GC, HPLC, and Karl Fischer technologies to ensure quality

• Aided in plant start up (Fermentation/Synthesis Departments); responsible for employee training and authoring of SOPs

• Working knowledge of ISO industrial hygiene practices and HAZMAT

• Performs/monitors confined space entries in accordance to OSHA regulated safety procedures

Education

Marquette University - Milwaukee, WI (5/96) Bachelor of Science Biology

Rochester Institute of Technology - Rochester, NY (Present) MS student Applied Statistics

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