Laura Monchinski Email & Phone Number

Quality Assurance and validation engineering professional with over 10 years of pharmaceutical and medical device industry experience offering a unique combination of analytical and technical skills, creative problem solving ability, and a commitment to quality and compliance with a customer service focus. Extensive experience in cleaning validation, equipment and utilities qualification and computer systems validation in fast-paced solid oral dosage pharmaceutical manufacturing environments. Additional experience with semi-solid, liquid, and aseptic operations as well as new product development process for medical devices including in vitro diagnostics. Highly skilled in managing multiple projects simultaneously with a proven record of successfully completed validation projects. Outstanding leadership and demonstrated ability to build rapport and credibility with diverse groups ranging from shop floor personnel to senior management.

Listed skills include Validation, 21 Cfr Part 11, Gmp, Computer System Validation, and 44 others.

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  Requirements Engineer

  Ventana Medical Systems

  Jan 2016 - Present - Tucson, Arizona Area