Senior Quality Compliance Specialist – Documentation

Grifols, S.A; Clayton (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Grifols, S.A in Clayton, NC is seeking a Sr. Quality Associate I in Quality Compliance to ensure documentation quality and regulatory compliance across manufacturing and testing.

The role involves coordinating document management, audits, data analysis, and leading teams on medium-scale projects. Responsibilities include authoring and revising documents, maintaining electronic batch records in Aizon, and collaborating with Manufacturing, QA, QC, Validation to meet quality metrics and CAPA

Qualifications

• The employee should hold a BA/BS in a STEM field with at least 5 years of quality/compliance experience.
• Strong written and verbal communication skills with ability to document and present findings.
• Experience reviewing manufacturing or testing reports and leading audits is preferred.

Responsibilities

• Maintain Qualified Author status and manage controlled documents in DMS/EBRs.
• Review documents for compliance with cGMPs and regulatory standards.
• Coordinate change control and CAPA-related documentation and reviews.
• Lead or participate in cross-functional project teams.
• Provide training on document control and author qualifications.
• Generate reports and monitor quality metrics and timelines.

Skills

Excellent communication skills

Quality mindset

Team leadership

Education

BA/BS in STEM field

5 years relevant experience

Tools

Document Management System (DMS)

Aizon Electronic Batch Record

Cosmos

Job description

Grifols, S.A in Clayton, NC is seeking a Sr. Quality Associate I in Quality Compliance to ensure documentation quality and regulatory compliance across manufacturing and testing.

The role involves coordinating document management, audits, data analysis, and leading teams on medium-scale projects. Responsibilities include authoring and revising documents, maintaining electronic batch records in Aizon, and collaborating with Manufacturing, QA, QC, Validation to meet quality metrics and CAPA