GMP Compliance Specialist — Audit Readiness & Quality Systems

Fresenius; Wilson (NC); Híbrido; USD 80.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401K with company contribution

Life insurance

Disability insurance

Wellness program

Descripción de la vacante

Fresenius Kabi is seeking a QA Compliance Specialist to work with the Compliance Management Team to identify and correct cGMP inadequacies at the Production Unit. You will help develop and implement Quality Systems to maintain audit readiness and regulatory compliance, and support APQR processes and regulatory requirements.

The role also involves supporting event initiation, investigations, and internal audits, as directed by the Compliance Management Team.

Formación

• Must be familiar with cGMP principles and regulatory expectations.

Responsabilidades

• Participates in multi-functional project teams as a Compliance representative.
• Coordinates and facilitates the Annual Product Quality Review (APQR).
• Ensures adherence to regulatory requirements through documentation and internal audits.

Descripción del empleo

Fresenius Kabi is seeking a QA Compliance Specialist to work with the Compliance Management Team to identify and correct cGMP inadequacies at the Production Unit. You will help develop and implement Quality Systems to maintain audit readiness and regulatory compliance, and support APQR processes and regulatory requirements.

The role also involves supporting event initiation, investigations, and internal audits, as directed by the Compliance Management Team.