Senior Quality Compliance Associate - Document Management

Grifols; North Carolina; On-site; USD 65,000 - 90,000; Full time

Job summary

Grifols in North Carolina seeks a Sr. Quality Associate I to support the Quality Compliance Department. The role focuses on document management, change controls, and regulatory alignment in a fast paced environment.

You may lead teams or projects while ensuring quality standards are met with minimal supervision. Ideal candidates will have QA experience, strong communication, and a background in STEM. Responsibilities include authoring, reviewing, and training others in quality processes and

Qualifications

• BA/BS in STEM with 5 years of relevant experience or equivalent combo.
• Experience writing, reviewing and coordinating quality documents.
• Understanding of cGMP and regulatory guidelines.

Responsibilities

• Maintain Qualified Author status for documents per SOPs and DMS.
• Coordinate development, review, routing, and historical filing in DMS/EBR.
• Review documents for cGMP compliance and regulatory requirements.
• Manage risk assessments, project plans, and change controls with teams.
• Generate reports and maintain Cosmos postings as needed.
• Assist in site regulatory inspections and supplier audits.
• Lead or participate in cross‑functional project teams.

Skills

Quality Control

Authoring

Regulatory awareness

Education

BA/BS in STEM

Job description

Grifols in North Carolina seeks a Sr. Quality Associate I to support the Quality Compliance Department. The role focuses on document management, change controls, and regulatory alignment in a fast paced environment.

You may lead teams or projects while ensuring quality standards are met with minimal supervision. Ideal candidates will have QA experience, strong communication, and a background in STEM. Responsibilities include authoring, reviewing, and training others in quality processes and