Senior Scientist, Assay Development & Quality

A-Line Staffing Solutions LLC; San Diego (CA); On-site; USD 62,000 - 89,000; Full time

Job summary

A-Line Staffing Solutions LLC is seeking a Senior Scientist – Assay Development & Quality in San Diego, CA to support reagent and assay product sustainment, technical documentation, and quality compliance. This role emphasizes cross-functional collaboration across Research, Quality, Regulatory Affairs, Manufacturing, Medical Affairs, and Operations.

The candidate should have a life sciences background with 5+ years of relevant experience, strong immunology and flow cytometry knowledge, and a

Qualifications

• Bachelor's degree in Life Sciences or a related field.
• At least 5 years of relevant experience in scientific research, a clinical or diagnostic laboratory, pharmaceutical R&D, or biotechnology.
• Strong understanding of immunology, flow cytometry, assay development, or related cell-based research technologies.
• Experience authoring, reviewing, and maintaining technical documentation and leading cross-functional projects.

Responsibilities

• Support sustainment and continuous improvement projects for marketed reagent and assay products.
• Review and approve technical documentation to ensure accuracy, completeness, and compliance.
• Evaluate design history files, validation reports, risk assessments, technical files, and product specifications.
• Ensure technical documentation aligns with applicable quality system requirements and regulatory expectations.
• Support change control activities and assess the impact of proposed product, process, and documentation changes.
• Serve as a technical subject matter expert during internal and external audits.
• Support audit preparation and ensure technical documentation is accurate and inspection-ready.
• Collaborate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support business objectives.

Skills

Immunology

Flow cytometry

Assay development

Education

Bachelor's degree in Life Sciences or related field

Job description

A-Line Staffing Solutions LLC is seeking a Senior Scientist – Assay Development & Quality in San Diego, CA to support reagent and assay product sustainment, technical documentation, and quality compliance. This role emphasizes cross-functional collaboration across Research, Quality, Regulatory Affairs, Manufacturing, Medical Affairs, and Operations.

The candidate should have a life sciences background with 5+ years of relevant experience, strong immunology and flow cytometry knowledge, and a