Quality Scientist: Immunoassay Analytics & CAPA Lead

Meso Scale Diagnostics, LLC.; Rockville (MD); On-site; USD 78,000 - 116,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company matching

Flexible spending accounts

Disability insurance

Job summary

Meso Scale Diagnostics, LLC is seeking a Quality Scientist to independently manage testing, technical transfer, and troubleshooting of protein-based immunoassays. The role may supervise others and collaborates with cross-functional teams to improve product and process quality.

Responsibilities include data analysis, MRB coordination, and CAPA initiation—while ensuring compliance with MSD processes and SOPs. A strong foundation in molecular biology and quality systems is essential.

Qualifications

• Bachelor's degree in a relevant field with 4+ years of experience required.
• Experience leading cross-functional teams and CAPA/ MRB processes.
• Strong background in protein-based immunoassays or related bioassays.
• Familiarity with quality systems, SOPs, and data integrity practices.

Responsibilities

• Review testing data and investigate failures; monitor product/process performance.
• Lead CAPA activities and MRB discussions, coordinating cross-functional teams.
• Present data-driven conclusions and recommendations to senior management.
• Develop and revise SOPs, test records, and product specifications.

Skills

Statistical analysis

Data analysis

Leadership

Communication

Project management

Teamwork

Problem solving

Attention to detail

DOE

Presentation skills

Education

Bachelor's degree

Tools

MS Office

MATLAB

MiniTab

Job description

Meso Scale Diagnostics, LLC is seeking a Quality Scientist to independently manage testing, technical transfer, and troubleshooting of protein-based immunoassays. The role may supervise others and collaborates with cross-functional teams to improve product and process quality.

Responsibilities include data analysis, MRB coordination, and CAPA initiation—while ensuring compliance with MSD processes and SOPs. A strong foundation in molecular biology and quality systems is essential.