Senior QC Scientist: Method Development & Validation

Grifols; San Diego (CA); On-site; CAD 161,000 - 195,000; Full time

Job summary

Grifols Diagnostic Solutions Inc. is seeking a QC Scientist to provide technical leadership in the Quality Control Laboratories. The role covers method validation, antigen release and stability, QC raw materials, and microbial QC, interacting with MS&T, Manufacturing and QA teams.

The candidate will develop and transfer analytical methods, troubleshoot, and support inspections, ensuring compliance with ICH and GrifolsQuality guidelines across multiple programs and equipment.

Qualifications

• Bachelor’s degree in Biochemistry, Molecular Biology, Immunology or related field; MS/PhD with relevant experience may be considered.
• Experience in GMP-regulated testing laboratories with analytical method validation and transfer.

Responsibilities

• Serve as resident expert for technical issues in specified QC areas.
• Lead staff development, mentoring and cross-training within QC.
• Troubleshoot processes with root cause analysis and drive improvements.
• Write and evaluate method validation protocols, reports, and development summaries.
• Assist management during inspections and audit observations.
• Plan and execute OE projects (5S, VSM, standard work).
• Ensure compliance with EH&S and Grifols Quality guidelines.

Job description

Grifols Diagnostic Solutions Inc. is seeking a QC Scientist to provide technical leadership in the Quality Control Laboratories. The role covers method validation, antigen release and stability, QC raw materials, and microbial QC, interacting with MS&T, Manufacturing and QA teams.

The candidate will develop and transfer analytical methods, troubleshoot, and support inspections, ensuring compliance with ICH and GrifolsQuality guidelines across multiple programs and equipment.