Senior Quality Scientist — Immunoassay Lead & CAPA Expert

Default (MSD); Rockville (MD); On-site; USD 88,000 - 134,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Job summary

MSD in Rockville, MD seeks a Senior Quality Scientist to independently manage testing priorities, design experiments for troubleshooting and product performance, and mentor analysts. Responsibilities include technical transfer, CAPA approvals, and guiding project teams while ensuring compliance with ISO standards.

The role emphasizes MRB coordination, problem solving, and leadership in a fast-paced environment focused on protein-based immunoassays and product release readiness.

Qualifications

• Bachelor's degree in life sciences or related field required; PhD preferred.
• Experience leading small teams and driving quality in ISO/GMP settings.
• Experience with protein immunoassays, and molecular biology basics.
• Proven ability to manage multiple high-impact projects with timelines.

Responsibilities

• Manage troubleshooting of non-conforming products and high-impact projects.
• Direct testing, analyze data, review and approve results.
• Approve CAPA documents (NCMRs/DEVs) and MRB outcomes.
• Lead MRB meetings and coordinate cross-functional reviews.
• Mentor analysts and associate scientists in methods and DOE.
• Develop SOPs, test records, and product specs.
• Ensure documentation complies with ISO standards.
• Support 5S and continuous improvement initiatives.

Skills

Leadership

Problem solving

Technical troubleshooting

Documentation & ISO

Communication

Project management

Quality systems

Excel/Office

Education

Bachelor's degree in Life Sciences

PhD preferred

Tools

MS Office

Excel

SharePoint

Access

LIMS

Job description

MSD in Rockville, MD seeks a Senior Quality Scientist to independently manage testing priorities, design experiments for troubleshooting and product performance, and mentor analysts. Responsibilities include technical transfer, CAPA approvals, and guiding project teams while ensuring compliance with ISO standards.

The role emphasizes MRB coordination, problem solving, and leadership in a fast-paced environment focused on protein-based immunoassays and product release readiness.