Senior QA Specialist: C&Q for Biotherapeutics Plant

NCBioImpact; Wilson (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Wilson, NC seeks a Senior QA Specialist - C&Q for our new Biotherapeutics Manufacturing facility. You will ensure regulatory compliance and lead qualification activities across the capital project lifecycle, from design through handover.

The role requires strong QA/adherence to cGMP and collaborative work with Operations, Engineering, and external partners to deliver a compliant, efficient site.

Formación

• Bachelor’s or Master’s degree in science or engineering.
• 6+ years in QA/validation in pharma/biotech.
• Experience with sterile/aseptic manufacturing preferred.

Responsabilidades

• Oversee QC/validation lifecycle (URS, CARA, IQ/OQ/PQ) and cleaning validation.
• Lead QA oversight of aseptic processing, sterilization, and PPE compliance.
• Review and approve validation protocols and reports.
• Support regulatory inspections and lifecycle management.

Conocimientos

QA & validation oversight

cGMP compliance

Regulatory standards knowledge

Technical writing

Cross-functional collaboration

Educación

Bachelor's in science/engineering

Master's preferred

Herramientas

Kneat

CSV/CSA

MS Office

Descripción del empleo

Johnson & Johnson in Wilson, NC seeks a Senior QA Specialist - C&Q for our new Biotherapeutics Manufacturing facility. You will ensure regulatory compliance and lead qualification activities across the capital project lifecycle, from design through handover.

The role requires strong QA/adherence to cGMP and collaborative work with Operations, Engineering, and external partners to deliver a compliant, efficient site.