Senior QC Biochemistry Validation Specialist

Grifols, S.A; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Grifols, S.A. is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project within the QC Biochemistry MD&V group. The role emphasizes immunology and tissue culture assays, test method development and validation, and contribution to regulatory submissions.

Experience with GMP environments is preferred; strong communication and data analysis skills are essential as is proficiency with instrument qualification and software validation.

Qualifications

• PhD in Biochemistry or Chemistry with minimal experience (Quality Associate II)
• MS in Biochemistry or Chemistry with 2 years relevant experience (Quality Associate II)
• BS in Biochemistry or Chemistry with 4 years relevant experience (Quality Associate II)
• PhD in Biochemistry or Chemistry with 1 year relevant experience (Quality Associate III)
• MS in Biochemistry or Chemistry with 3 years relevant experience (Quality Associate III)
• BS in Biochemistry or Chemistry with 5 years relevant experience (Quality Associate III)
• PhD in Biochemistry or Chemistry with 2 years relevant experience (Senior Quality Associate)
• MS in Biochemistry or Chemistry with 4 years relevant experience (Senior Quality Associate)
• BS in Biochemistry or Chemistry with 6 years relevant experience (Senior Quality Associate)

Responsibilities

• Support immunology and tissue culture assays in QC Biochemistry
• Develop, validate, transfer, and replace test methods
• Assist in assay automation to improve efficiency
• Prepare protocols and reports for regulatory submissions
• Write test procedures and validation reports
• Interpret data and contribute to investigations
• Participate in experimental design under senior staff guidance
• Ensure GMP-compliant documentation and software validation

Skills

Immunology

Immunochemistry

Biochemistry

Test method development

Validation studies

Instrument qualification

Regulatory submission docs

MS Word

Excel

JMP

Education

PhD Biochemistry

MS Biochemistry

BS Biochemistry

Tools

Instrument qualification software

Spreadsheet validation

Job description

Grifols, S.A. is seeking a Sr. Quality Associate to support the Fibrinogen Transfer Project within the QC Biochemistry MD&V group. The role emphasizes immunology and tissue culture assays, test method development and validation, and contribution to regulatory submissions.

Experience with GMP environments is preferred; strong communication and data analysis skills are essential as is proficiency with instrument qualification and software validation.