Senior QC Biochemistry & Validation Specialist

Grifols; Clayton (NC); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Grifols in Clayton, NC is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project. The role focuses on biochemistry method development, validation, transfer, and regulatory-compliant documentation.

Experience with immunology and tissue culture assays is strongly preferred; familiarity with ELISA and analytical methods will help in method development and validation. Grifols offers opportunities in a global healthcare environment with emphasis on regulatory compliance and

Qualifikationen

• PhD in Biochemistry or Chemistry (M06) with minimal experience; MS with 2+ years; BS with 4+ years
• PhD in Biochemistry or Chemistry with 1 year; MS with 3 years; BS with 5 years for M07
• PhD in Biochemistry or Chemistry with 2 years; MS with 4 years; BS with 6 years for M08

Aufgaben

• Support Fibrinogen Transfer Project within QC Biochemistry MD&V.
• Perform or assist biochemistry test method development, validation, transfer, and replacement.
• Assist assay troubleshooting and instrument qualification.
• Prepare validation studies, protocols, and reports for regulatory review.
• Assist in replacement or transfer of test methods to improve assay performance and efficiency.
• Write test procedures, validation reports, method development reports, and investigation reports.

Jobbeschreibung

Grifols in Clayton, NC is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project. The role focuses on biochemistry method development, validation, transfer, and regulatory-compliant documentation.

Experience with immunology and tissue culture assays is strongly preferred; familiarity with ELISA and analytical methods will help in method development and validation. Grifols offers opportunities in a global healthcare environment with emphasis on regulatory compliance and