QA COE Senior Specialist: Validation & Compliance

MSD; Wilmington (DE); Presencial; USD 106.000 - 167.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement benefits

401(k) plan

Paid holidays

Vacation days

Sick days

Descripción de la vacante

MSD Malaysia in Wilmington, USA is seeking a Senior Specialist for the Quality Center of Excellence to ensure processes meet company policies and regulatory requirements, delivering Right First Time product quality for life-saving medicines.

The role involves commissioning, qualification, and validation of facilities, utilities, and equipment, with collaboration across operations, IT, and engineering to maintain data integrity and continuous improvement.

Formación

• Minimum 5 years in Quality Control, QA or pharma operations.
• Experience in commissioning, qualification, and validation.
• Strong knowledge of cGMPs and regulatory trends.

Responsabilidades

• Oversee QC/QA activities for commissioning, qualification, validation.
• Collaborate with site operations, IT, and engineering for quality input.
• Ensure compliance with regulatory expectations and company policies.
• Lead validation reviews across utilities, equipment, and processes.

Conocimientos

Quality Assurance

cGMP Regulations

Validation

CAPA

Lean QA

Educación

Bachelor's degree in Chemistry, Biology, Microbiology, Automation, Engineering

Descripción del empleo

MSD Malaysia in Wilmington, USA is seeking a Senior Specialist for the Quality Center of Excellence to ensure processes meet company policies and regulatory requirements, delivering Right First Time product quality for life-saving medicines.

The role involves commissioning, qualification, and validation of facilities, utilities, and equipment, with collaboration across operations, IT, and engineering to maintain data integrity and continuous improvement.