Remote Principal Clinical Compliance 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

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.