Senior Scientist, Assay Development & Quality

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

Job summary

A-Line Staffing Solutions LLC in Milpitas, CA is seeking a Senior Scientist – Assay Development & Quality to advance immunology, flow cytometry, and assay development within a regulated quality framework. This on-site role focuses on documentation, audits, and cross-functional collaboration.

You will review technical files, support change control, and partner with Regulatory Affairs, Quality, Manufacturing, and Medical Affairs to ensure product quality from development through lifecycle.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years of experience in scientific research, clinical or diagnostic laboratory, pharma R&D, or biotech.
• Strong understanding of immunology, flow cytometry, and assay development.
• Experience authoring, reviewing, and maintaining technical documentation.
• Ability to lead projects independently and collaborate across teams.
• Excellent written and verbal communication; detail-oriented and compliant.

Responsibilities

• Support sustainment and continuous improvement projects for marketed reagent and assay products.
• Review and approve technical documentation for accuracy and compliance.
• Evaluate design history files, validation reports, risk assessments, and product specs.
• Ensure documentation meets quality system and regulatory expectations.
• Support change control activities and assess impact of product changes.
• Act as SME during audits and support audit readiness.
• Collaborate with Regulatory, Quality, Marketing, Manufacturing, Medical Affairs, and Operations.
• Contribute to product quality and lifecycle improvements.

Skills

Immunology

Flow cytometry

Assay development

Technical documentation

Project leadership

Written and verbal communication

Education

Bachelor's degree in Life Sciences

Job description

A-Line Staffing Solutions LLC in Milpitas, CA is seeking a Senior Scientist – Assay Development & Quality to advance immunology, flow cytometry, and assay development within a regulated quality framework. This on-site role focuses on documentation, audits, and cross-functional collaboration.

You will review technical files, support change control, and partner with Regulatory Affairs, Quality, Manufacturing, and Medical Affairs to ensure product quality from development through lifecycle.