Amy Polinske
SDS Author at Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group- Claim this Profile
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Bio
Experience
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Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group
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Pharmaceutical Manufacturing
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1 - 100 Employee
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SDS Author
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Mar 2022 - Present
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LA-CO Industries, Inc.
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United States
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Chemical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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Apr 2021 - Mar 2022
- Continued regulatory work that was performed previously in a full-time capacity.- Draft RoHS, REACh, SVHC, Prop-65, and Conflict Mineral compliance certifications per customer requests.- Manage NSF, IAPMO, UL, and CSA certifications for plumbing products, including certification set-up for private label customers.- Request, inspect, and manage SDS information for products in LA-CO’s portfolio- Request, inspect, and manage label content for products in LA-CO’s portfolio- Complete customer regulatory surveys received. Show less
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Research and Development Chemist
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Sep 2013 - Apr 2021
- Researched and developed color changing mechanism for sterilization ink to grow businesst $600,000.- Assisted customers with achieving 510K approval from the FDA.- Led Corrective Action Reporting committee for three years in investigating customer complaints and internal improvements.- Perform technical support duties, including assisting customers in application recommendations, trouble shooting issues, and relaying product information.- Work directly with manufacturing with scale-up and process improvement.- Draft RoHS, REACh, SVHC, Prop-65, and Conflict Mineral compliance certifications per customer requests.- Manage NSF, IAPMO, UL, and CSA certifications for plumbing products, including certification set-up for private label customers.- Manage customer print requests for sterilization indicating inks.- Joined Sales and Marketing in integrating California Prop-65 compliance for LA-CO’s portforlio of products- Completed customer regulatory surveys received Show less
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LAB TECHNICIAN
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2006 - 2013
- Researched and developed continuous solvent based inkjet black ink for 50% cost savings. - Researched and developed piezo drop on demand water based black, cyan, magenta, and yellow inks for 28-37% cost savings. - Formulated additional water based and solvent based continuous inkjet ink, water based piezo drop on demand inkjet, UV piezo drop on demand inkjet, and water based thermal drop on demand inkjet. - Worked directly with Finishing and Press Departments for developing and improving ink products. - Experience with method development and testing for quality control of raw materials and production batches. - Use of analytical skills for trouble shooting and formulation of inks. - Performed method development and maintenance on laboratory instrumentation. - Plant Emergency Organizer and active in safety initiatives. - Six Sigma Green Belt and training in Lean Manufacturing. Show less
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Education
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UNIVERSITY OF WISCONSIN WASHINGTON COUNTY
Chemistry