Senior QC Biochemistry & Method Validation Specialist

Grifols; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Grifols in North Carolina is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project and ensure regulatory compliance within a GMP biochemistry QC lab.

You will develop and validate test methods, transfer methods, write protocols and reports, and collaborate with senior QC staff to improve assay performance and documentation.

Strong data analysis and communication skills, plus experience with ELISA, assays, and instrument qualification preferred.

Qualifications

• Hands-on immunology/tissue culture assay experience in QC Biochemistry.
• Experience in test method development/validation and regulatory reports.
• GMP experience preferred; strong writing and communication skills.
• Proficient with MS Word, JMP, and Excel.

Responsibilities

• Support Fibrinogen Transfer Project and QA in a GMP lab.
• Perform validation studies and prepare protocols/reports.
• Assist in transfer of test methods to improve assay performance.
• Document procedures, method development, and investigations.

Education

PhD Biochemistry

MS Biochemistry

BS Biochemistry

Immunology

Immunochemistry

Test method development

Test method validation

Assay automation

Instrument qualification

Statistical data analysis

MS Word

JMP

Excel

Regulatory submissions

Tools

JMP

Excel

Software validation

Job description

Grifols in North Carolina is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project and ensure regulatory compliance within a GMP biochemistry QC lab.

You will develop and validate test methods, transfer methods, write protocols and reports, and collaborate with senior QC staff to improve assay performance and documentation.

Strong data analysis and communication skills, plus experience with ELISA, assays, and instrument qualification preferred.