Senior Quality Compliance Lead - Document Control & Audits

Grifols; Clayton (NC); Sur place; USD 65 000 - 95 000; Plein temps

Résumé du poste

Grifols, located in Clayton, NC, is seeking a Sr. Quality Associate I for the Quality Compliance team. The role focuses on document governance, cGMP compliance, and data-driven improvement across manufacturing and QA systems.

You may lead teams, train staff, and drive regulatory readiness while ensuring quality objectives are met. Responsibilities include authoring and revising documents, managing DMS and Aizon records, and coordinating audits and CAPA-related activities in a fast-paced

Qualifications

• BA/BS in a STEM field with 5+ years of relevant experience.
• Experience with cGMPs and regulatory requirements.
• Ability to train others and work cross-functionally.

Responsabilités

• Maintain Qualified Author status for document creation and revisions per SOPs.
• Manage documents in DMS and Aizon EBR for BPRs/SOPs/EBRs and historical files.
• Review documents for compliance with cGMPs, cGDocPs, and regulatory standards.
• Coordinate reviews, routes for disposition, publishing, and archival in the DMS.
• Execute changes to electronic batch record Master Recipes in Aizon.
• Distribute and manage periodic reviews and related notifications.
• Conduct instructor-led training for author qualifications.
• Author/review/approve Change Controls, Incident Tracking entries and investigations.
• Represent Quality Document Management in cross-functional discussions.

Connaissances

Quality Assurance

Documentation

Regulatory knowledge

Data analysis

Formation

Bachelor's degree in STEM

Outils

Document Management System (DMS)

Aizon Electronic Batch Records

Description du poste

Grifols, located in Clayton, NC, is seeking a Sr. Quality Associate I for the Quality Compliance team. The role focuses on document governance, cGMP compliance, and data-driven improvement across manufacturing and QA systems.

You may lead teams, train staff, and drive regulatory readiness while ensuring quality objectives are met. Responsibilities include authoring and revising documents, managing DMS and Aizon records, and coordinating audits and CAPA-related activities in a fast-paced