Associate Quality Scientist, Immunoassays & CAPA Lead

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 68,000 - 101,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) plan with company matching

Paid vacation and holidays

Paid parental leave

Employee assistance program

Job summary

Meso Scale Diagnostics LLC in Rockville, MD is seeking an Associate Quality Scientist to independently manage testing, transfer, and troubleshooting of protein-based immunoassays. You will address failures and document findings, guiding next steps. This role may supervise others across interdisciplinary teams.

Responsibilities include leading CAPA activities, MRB meetings, SOP development, and ensuring compliance with MSD processes while supporting safe, efficient lab operations.

Qualifications

• Bachelor's degree required with 2 years of relevant experience.
• Additional education may substitute for experience.
• Additional experience may substitute for degree.

Responsibilities

• Review testing data and perform analyses including investigations of failures and trend monitoring.
• Provide descriptive statistical analysis ensuring accuracy and validity of data.
• Conduct experiments, summarize results, and present recommendations to cross-functional teams including senior management.
• Lead MRB meetings and facilitate discussions.
• Initiate and lead CAPA documents (Deviations, NCMR, etc.).
• Establish direct report performance and development goals and provide feedback on performance.
• Identify process and product improvements using product data and metrics as a guide.
• Develop, revise and implement SOPs, Test Records, and product specification documents.

Skills

Protein-based immunoassays

Immunoassay troubleshooting

Statistical analysis

Laboratory safety

Design of Experiments (DOE)

Cross-functional leadership

Documentation & SOP development

Data visualization & interpretation

Communication skills

MS Office proficiency

Data analysis tools

Statistical software (MATLAB/MiniTAB)

Education

Bachelor's degree in a relevant field

Tools

MATLAB

MINITAB

Job description

Meso Scale Diagnostics LLC in Rockville, MD is seeking an Associate Quality Scientist to independently manage testing, transfer, and troubleshooting of protein-based immunoassays. You will address failures and document findings, guiding next steps. This role may supervise others across interdisciplinary teams.

Responsibilities include leading CAPA activities, MRB meetings, SOP development, and ensuring compliance with MSD processes while supporting safe, efficient lab operations.