GMP Quality Assurance Lead

Granules; Suffolk (VA); Presencial; USD 80 000 - 120 000; Tempo integral

Resumo da oferta

Granules in Suffolk, VA is seeking a Quality Lead to support cGMP compliance, documentation, deviation management, CAPAs, audits, and continuous improvement. This individual contributor role offers growth into a people management path and works across QA, operations, and regulatory activities.

You will manage controlled GMP documents, review SOPs, maintain QA databases, track change requests, and help ensure an inspection-ready environment.

Qualificações

• Strong knowledge of cGMP/GxP, FDA regulations, and regulatory requirements.
• Experience with Deviations, Investigations, CAPAs, and Change Controls.
• Knowledge of QA databases, document repositories, and QMS/EDMS platforms.

Responsabilidades

• Manage the lifecycle of controlled GMP documents including issuance, revision, and archival.
• Author, review, and maintain SOPs, protocols, and batch records for compliance.
• Maintain QA databases and tracking systems in an inspection-ready state.
• Track and review change requests, logbooks, and required records for timely completion.
• Ensure compliance with cGMP, DEA, SOPs, and regulatory requirements.
• Support QMS activities including deviations, CAPAs, investigations, and closures.
• Coordinate investigations, non-conformances, and customer complaints to identify root causes and corrective actions.
• Assist with inspections, material disposition, and documentation reviews.
• Support warehouse/distribution QA activities and vendor qualifications.

Conhecimentos

cGMP/GxP knowledge

FDA regulations

QMS/EDMS processes

Documentation practices

Analytical skills

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

TrackWise

Veeva

Microsoft Office

Descrição da oferta de emprego

Granules in Suffolk, VA is seeking a Quality Lead to support cGMP compliance, documentation, deviation management, CAPAs, audits, and continuous improvement. This individual contributor role offers growth into a people management path and works across QA, operations, and regulatory activities.

You will manage controlled GMP documents, review SOPs, maintain QA databases, track change requests, and help ensure an inspection-ready environment.