Principal Clinical Technical Specialist

Waters Corporation; Chicago (IL); Remote; USD 85,000 - 115,000; Full time

Job summary

Waters Corporation is seeking a Clinical Field Reviewer to assess clinical records for compliance with our service protocols and cGMP guidelines. The role collaborates with the Quality Group to ensure timely, thorough complaint investigations across domestic and international sites.

The ideal candidate holds a bachelor’s degree in science or related field and 3+ years in complaint handling or record review, with LC/MS instrumentation experience or willingness to train.

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 LC/MS instrumentation or ability to attend and pass Waters instrumentation training.
• Experience with Customer Complaint Handling in biotech, 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.

Responsibilities

• Review and close customer complaints within Compass.
• Review non-complaint clinical records for adherence to 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.

Skills

Communication skills

Attention to detail

Organization

Networking

Team cooperation

Customer interaction

Education

Bachelor’s degree in science or related field

Tools

LC/MS instrumentation

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