Lead Quality Assurance: Filling Operations

Grifols, S.A; Clayton (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Grifols, S.A. in Clayton, NC seeks a Sr. Quality Associate II / Principal Quality Associate for the Quality Assurance Filling Business Unit. You will review manufacturing or testing records, investigate deviations, and lead cross-functional teams to ensure compliant product releases.

The role emphasizes development and maintenance of Grifols technologies, regulatory document preparation, and participation in APRs. Strong QA leadership and communication skills are essential for this senior role.

Qualifications

• BA/BS in STEM with 6 years of relevant experience or an equivalent combination.
• Equivalency may include related education, experience, and competencies.
• Principal Quality Associate requires BS/BA in STEM with minimum 8 years of relevant experience.

Responsibilities

• Advise and influence technical decisions for business units using expertise.
• Develop, maintain and ensure vitality of key Grifols technologies.
• Interact with management and regulatory officials as needed.
• Lead multi-disciplinary project teams to successful completion.
• Prepare/review SOP revisions, Change Control and investigation reports.
• Prepare sections of the Annual Product Review and APR.
• Represent Quality manager at meetings and provide QA input.

Skills

Quality Assurance

Leadership

Regulatory awareness

Education

BS/BA in STEM

Tools

SAP

SAP Quality Module

Change Control

Job description

Grifols, S.A. in Clayton, NC seeks a Sr. Quality Associate II / Principal Quality Associate for the Quality Assurance Filling Business Unit. You will review manufacturing or testing records, investigate deviations, and lead cross-functional teams to ensure compliant product releases.

The role emphasizes development and maintenance of Grifols technologies, regulatory document preparation, and participation in APRs. Strong QA leadership and communication skills are essential for this senior role.