QA & Validation Specialist – QC Compliance (Biotech)

FUJIFILM Biotechnologies; Holly Springs (NC); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, QC Compliance to partner in the Quality oversight of the QC laboratory program. The role drives validation and lifecycle management for lab processes, ensuring systems stay validated and aligned with regulatory expectations.

The candidate will collaborate with global peers, manage risk documentation, and support inspections. A strong background in GMP/QC and validation is required, with flexibility for 24/7 manufacturing

Formación

• Bachelor's or Master's degree in Life Sciences or Engineering with GMP-related experience preferred.
• 1-3 years of experience in a GMP environment and/or GMP Quality Assurance roles.
• Experience in validation, cGMP manufacturing operations, and/or QA oversight in an FDA-regulated facility.

Responsabilidades

• Provides QA oversight for QC laboratory processes and project deliverables.
• Manages change control and ensures lab systems remain validated from startup through commercial operation.
• Approves laboratory system and process documentation, qualification protocols, validation plans and summary reports.
• Generates and approves QA procedures for validation approaches and lifecycle documents for equipment and systems.
• Ensures timely achievement of project and operational quality objectives and collaborates across sites to streamline processes.

Conocimientos

QA oversight

GMP compliance

Change management

Documentation control

Educación

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

Herramientas

Trackwise

MasterControl

Kneat validation

Smartsheet

Descripción del empleo

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, QC Compliance to partner in the Quality oversight of the QC laboratory program. The role drives validation and lifecycle management for lab processes, ensuring systems stay validated and aligned with regulatory expectations.

The candidate will collaborate with global peers, manage risk documentation, and support inspections. A strong background in GMP/QC and validation is required, with flexibility for 24/7 manufacturing