Principal Clinical Technical Specialist

Waters Corp
  • Kansas City, MO
    4 days ago

    Job Description

    Overview

    Waters Corporation''s Field Services Organization is comprised of highly skilled, motivated, and customer-focused professionals. In this role the Clinical Field Reviewer is responsible for reviewing all clinical records for compliance to our established clinical service protocols. In addition, person will follow our Clinical Complaint Handling process for Waters Clinical product offerings ensuring a high level of cGMP compliance. In this role you will work closely with our Quality Group to ensure complaint records from the field are compliant with current processes and are completed in a timely manner.

    This position will be remote based and can be flexible in location.

    Responsibilities

    • Review and close customer complaints within Compass
    • Review non-complaint clinical records for adherence to our internal processes
    • Provide metrics associated with the review of clinical records
    • Work closely with the Quality Group to ensure complaint investigations are complete, thorough, and meet regulatory reporting requirements both domestic and international
    • Conduct real-time installation reviews of clinical systems during the installation process

    Qualifications

    • Minimum bachelor's degree in science or related field, will also consider applications with equivalent experience, training and education.
    • Minimum of 3+ years work experience on complaint handling, record review, or project management type activities.
    • Experience working with our LC/MS instrumentation is a requirement or having the ability to attend and pass training courses on Waters instruments.
    • Experience with Customer Complaint Handling in the biotechnology, medical device or pharmaceutical industry preferred
    • Proven track record of excellent organization skills and attention to detail
    • Excellent oral and written communication skills
    • Result oriented with a balance of excellent team cooperation
    • Strong networking and communication skills to interact with customers and internal Waters staff
    • Exceptional work ethic with proven experience working with other groups to achieve shared goals.

    Company Description

    Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

    Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.

    Key Words

    Chromatography, Management, Field Manager, Service, Mass Spectroscopy

    Numbers & Facts

    LocationKansas City, MO

    Skills

    • Analysis Skillsunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Chemistryunmatched
    • Chromatographyunmatched
    • Clinical Information Systemsunmatched
    • Clinical Medicineunmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Validationunmatched
    • Communication Skillsunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Customer Relationsunmatched
    • Detail Orientedunmatched
    • Diseaseunmatched
    • Diversityunmatched
    • Employee Benefitsunmatched
    • Food Safetyunmatched
    • Geneticsunmatched
    • Infection Controlunmatched
    • Informaticsunmatched
    • Instrumentationunmatched
    • Liquid Chromatography-Mass Spectrometry (LC-MS)unmatched
    • Medical Conditionsunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Medical Recordsunmatched
    • Metricsunmatched
    • On Site Supportunmatched
    • Organizational Skillsunmatched
    • Physicsunmatched
    • Presentation/Verbal Skillsunmatched
    • Project/Program Managementunmatched
    • Regulatory Reportsunmatched
    • Regulatory Requirementsunmatched
    • Resolve Customer Issuesunmatched
    • Safety/Work Safetyunmatched
    • Spectroscopyunmatched
    • Systems Administration/Managementunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Writing Skillsunmatched

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