Senior QA COE Specialist — Validation & Compliance

Merck & Co.; Wilmington (DE); Híbrido; USD 106 000 - 167 000; Tempo integral

Resumo da oferta

Merck & Co. seeks a Senior Quality COE Specialist in Delaware to support commissioning, qualification, and validation activities, ensuring cGMP compliance and regulatory alignment. The role collaborates with global teams to drive quality improvements and data integrity across facilities and labs.

You will work across URS, FAT, SAT, IQ/OQ/PPQ processes, support SQM, and help maintain a robust quality culture for high-potency development and manufacturing.

Qualificações

• Minimum 5 years of experience in Quality Control, Quality Assurance or Pharmaceutical/ Biologics operations.
• Strong knowledge of cGMPs, regulations and current industry trends.
• Experience with commissioning, qualification and validation activities.

Responsabilidades

• Quality aspects of commissioning, qualification, and validation of facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with policies and regulatory expectations.
• Participate in quality activities for commissioning, qualification and validation impacting product quality, patient safety, or data integrity.
• Collaborate with site operations, quality operations, IT, automation, and engineering to provide quality input during qualification/validation and drive continuous improvement.
• Work on URS, FAT, SAT, IQ, OQ, PPQ, and commercialization processes.
• Quality oversight of validation activities across the site including cleaning validation, utilities qualification, process validation, and equipment requalification.
• Provide quality oversight of the Lab on site and ensure Lab operates to Manufacturing Division Quality Manual requirements.
• Support and maintain the Supplier Quality Management (SQM) process at the site.
• Understand manufacturing processes to ensure equipment and facilities meet process needs and regulatory expectations.
• Knowledge of US and European cGMP guidelines, ICH and other regulatory requirements.

Conhecimentos

Quality Control

Quality Assurance

Regulatory knowledge

Analytical skills

Problem solving

CAPA management

cGMP regulations

Change management

Documentation understanding

Process improvement

Team leadership

Communication

Planning & scheduling

Risk management

Decision making

Root cause analysis

Formação académica

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

Descrição da oferta de emprego

Merck & Co. seeks a Senior Quality COE Specialist in Delaware to support commissioning, qualification, and validation activities, ensuring cGMP compliance and regulatory alignment. The role collaborates with global teams to drive quality improvements and data integrity across facilities and labs.

You will work across URS, FAT, SAT, IQ/OQ/PPQ processes, support SQM, and help maintain a robust quality culture for high-potency development and manufacturing.