Katherine Elmore Email & Phone Number

Eagan, Minnesota, United States

As part of a team and individually in Ecolab's Packaging Lab department, I preformed conditioning, physical, and ASTM testing for chemical, life science, and medical product packing configurations. The testing results and data was documented using electronic datasheets and image media. The testing status and results was communicated with the engineers.• Preformed and completed a Design Change Case Configuration study testing 4 packing variations with 2 conditioning levels• Completed testing and documentation for over 100 work requests.• Promote improvements for lab efficiency

Arden Hills

• In the Rhythm Management Catheter and Leads Department I preformed physical, electrical, pressure, conditioning, and tensile tests on medical products.• Worked and completed assigned Design Verification, Design Analysis, Experiment, Gage R&R, and Development testing with a team and/or independently.• Actively communicates with engineers over scheduling, test standards, changes and status of assigned R&D work orders.• Revise, redline, create and propose documentation in Excel and Word to clarify and document test data, procedures, standards and changes. • Transfer essential work order’s data and procedures into electronic storage when work order is released by engineerExamples of type of mechanical testing I am familiar with is torque, electrical, catheter conditioning, MTS tensile testing. I am comfortable using with various of microscopes for inspection, angle determination, and photo documentation. The medical devices I am familiar working with is the Boston Scientific Orion, Intellatip catheters, and leads.

Maple Grove, Mn

.At Boston Scientific I support material testing on a R&D medical device. This entails not only various testing methods, it also involves troubleshooting evolving testing methods and products for continuous improvement. Data output produced is documented in various media forms and formats (Picture, Video,Excel,Datasheets, PDF format, Word). Another way I supported my team is capturing current and evolving testing methods by writing down their protocol into SOPs and building a base for final DA testing validation document.I played a major role in developing, testing, and writing the test method of 3 prerelease SOP validation test protocols.Examples of type of material testing I am familiar with is torque, track tester, Instron tensile and compression testing. I am comfortable using with various of microscopes, filtration, and soldering. The medical devices I am familiar working with is the Boston Scientific AngioJet System and its supporting catheters.

Chanhassen, Mn

During my time at Federal Package I resolved and preformed return product testing and quality assurance holds.• I created and improved Excel programs to efficiently present data results from product force testing.• I worked to resolved products that has been put on hold for over a year.• I accomplished all my assigned projects a week earlier by working efficientlySkills used• Product inspection and application force testing.• Communicating the results verbally, in forms and Excel.• Final Review of production quality paperwork

South South St. Paul, Mn

Daily worked and assisted Food Safety Supervisor to maintain regulatory and subcontractor's compliance requirements in a 24hr bakery.• I discovered and reported labeling errors while reviewing qc documents. I then tracked the product on the floor and put them on hold.• During a product audit, I discovered a labeling error in the product before it was shipped out of the warehouse.• I discovered ingredients not in the approved product list during a monthly audit of ingredients• I alerted management to a chain conveyor belt breakdown discovered in my biweekly plant audit in its early stages; as a result, adjunct belts were not ruined and downtime was reduced to 30 mins.Skills Used:• Reviewing quality documentation• Auditing manufacturing facility• Calibration testing of scales, temperatures monitor and sterilization dispensers• Inventories product ingredients in facility.• Communicating with production workers, Maintenance and Supervisors of non-conformities and repairs needed in the production facility.• Monitor the Pest Control program of the production facility.• Inspects shelf life and incoming flour ingredient daily.• Media communication of non-conformities in manufacturing facility.

New Hope, Mn

Provide Quality Assurance support in a fast, continuous changing food manufacturing and production plant to ensure the safety and compliance of the product to satisfy the customer.• I modified, updated and created over 100 incoming product inspection forms to the same format• In the middle of an audit I traced a reported infestation back to its source in the stockroom, documented, and settled the issue before it was observed by the auditor.• I brought attention to low air pressure and wrong metal detector being used on packing lines when product bag is over 8 ounces.Skills Used● Verifications (mixing, formulation, metal and packaging) of work in process in production and packaging.● Coordinating with production, warehouse, buyer and vendor staff to address and document various nonconformance issues; created and closed non-nonconformance reports in Microsoft ACCESS.● Reviewing quality documents and addressed noncompliance issues and document corrections.● Testing for temperature, moisture, taste and salt content to ensure product quality standards.● Preformed instrument calibrating of scales and checks on controlled items.● Inspecting production and packaging equipment for allergen and organic cleaning.

Chaska, Mn

Provide a wide range of quality technician duties to ensures compliance of manufactured instruments for release . Records and maintain accurate documentation. Reviewed control documents. Trains new employees on department procedures.• While going through instrument traveler during my down time, several times I found and reported that an instrument was not given a major pre QC test.• I developed a system to ensure that essential supplies would be in the correct temperature for instrument use• Working with a team, I help meet monthly production goals of both products for two months after two weeks of training• I discovered and reported that the lid to manufactured instruments was not easily closing flush. This directly affecting its function and resulted in a HACCP.● Detected missing and incorrect instrumental tests and initiated the process to address the issue cutting instrument first review time by 25%.● Detected instrument nonconformance by inspection and analyzation of its test data.● Developed a system to ensure a continuous supply of essential supplies at the correct temperature in the department.● Ensuring departmental compliance by developing a schedule in the instrument quality department for making weekly expired testing solutions.● Preformed a battery of tests, calibrations and maintenance on an average of 4-15 manufactured instruments per day.● Decrease instrument duration in final test by physical inspection, analyzation of instrument test results and addressing any nonconformance immediately● Achieved the quality department instrument output goals for two consecutive months.● Trained new employees on Final Test procedures whose addition decreased instrument testing time and increased department instrument output.

Webster, Tx

• I reported discoveries of nonconformance in product labeling and document control records prior to product release.• I discovered mislabeled reagent bottles and reported it.• During lab equipment calibration, I discover incorrect settings fixed it and reported it.• While I was monitoring freezer and refrigerator temperature, I found out, reported, and moved items from them when temps are out of spec.● Conducts multiple different quality control testing of over 100 product kits and their components daily to release products before biweekly shipment date.● Preformed validation testing process for four products. ● Upholding QC quality and compliance by establishing accepted concentration ranges of QC controls to be used in kit testing.● Ensuring continuous supply of lab consumables and equipment by ordering and maintaining inventory. ● Maintain QC laboratory and equipment to ensure FDA and ISO compliance.● Discovered out of specification errors in products, labels and related document control records before they become major issues.● Trained technicians on equipment calibration, preventative maintenance and on preforming complex assays creating back-up for processes while increasing efficiencies. ● Detected when instrumentation is out of spec and take steps to remedy before product is affected preventing non-compliance. ● Establishing LEAN practices in the quality control department increasing work efficacy.

Houston, Tx

● Identified an operational process area not covered in a SOP and took initiative to document the process.● Trouble-shoot and resolved re-suspension calculations calculation errors in SOP document and computer program reducing cell dilution repeats.● Ensure FDA lab compliance by preforming clean lab maintenance and environmental monitoring.● Initiated nine tissue culture lines and processed eleven harvests with no contamination of cell cultures in an antibiotic-free clean room site.● Discovered fungi growth in clean lab incubators drainage channels and address the issue resulting in reducing contamination of cultures.● Trouble-shoot and resolved re-suspension calculations calculation errors in SOP document and computer program reducing cell dilution repeats.● Took initiative to clearly document the process of changing CO2 tanks so other production technicians can preform the tasks creating backup of essential lab maintenance processes.

Bachelors Of Science, Biology

Associate’S Degree, Computer And Information Sciences And Support Services