Senior QA Data Integrity Lead - GxP Computer Systems

Grifols, S.A; Clayton (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Grifols, S.A. seeks a Principal Quality Associate to oversee data integrity initiatives for GxP computer systems in Manufacturing and QC Laboratories. The role involves reviewing validation documentation, and guiding change control and periodic review to ensure ongoing regulatory compliance.

The position requires a STEM degree with eight years of relevant experience for the Principal level, with senior levels demanding five or more years. Day shift; regular full-time employment.

Qualifications

• BS/BA in STEM discipline with minimum 5 years relevant experience for Sr. Quality Associate I/II; higher years for Sr. II and Principal.
• Experience with GxP computer systems and data integrity is implied by role.

Responsibilities

• Lead and support data integrity risk assessments for GxP computer systems in Manufacturing and QC Laboratories.
• Provide QA oversight for access controls, audit trails, and electronic records/electronic signatures to comply with 21 CFR Part 11 and EU Annex 11.
• Review and approve validation lifecycle documentation and collaborate with system owners to maintain controlled validated states.

Education

BS/BA in STEM

5+ years relevant experience

8+ years relevant experience for Principal

Job description

Grifols, S.A. seeks a Principal Quality Associate to oversee data integrity initiatives for GxP computer systems in Manufacturing and QC Laboratories. The role involves reviewing validation documentation, and guiding change control and periodic review to ensure ongoing regulatory compliance.

The position requires a STEM degree with eight years of relevant experience for the Principal level, with senior levels demanding five or more years. Day shift; regular full-time employment.