Senior QC Lead, Bioanalytical Sciences

Amgen Inc.; Dún Laoghaire; Teletrabalho; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Amgen Ireland seeks a QC Senior Associate to lead and coordinate activities in the QC Bioanalytical Sciences laboratory at the manufacturing site. The role focuses on lab operations, compliance, continuous improvement projects, and acting as a role model for colleagues, with minimal supervision.

You will drive lean initiatives, support Right First Time goals, and represent the QC unit in interactions with customers and regulatory bodies, while contributing to procedure development and validation

Qualificações

• Hold a third level qualification in biology/biotechnology or related discipline.
• Experience with regulatory inspections and interaction with inspectors is preferable.
• Experience leading cross-functional teams and influencing decisions.

Responsabilidades

• Lead and coordinate QC activities in the Bioanalytical Sciences laboratory.
• Ensure compliance with cGLP and cGMP within the QC unit.
• Participate in regulatory inspections and liaise with internal/external customers.
• Provide technical guidance, training, and problem solving to staff.

Conhecimentos

Excellent communication

Regulatory knowledge

Cross-functional leadership

Problem-solving

Team training

Formação académica

Degree in Biology/Biotechnology or related

Descrição da oferta de emprego

Amgen Ireland seeks a QC Senior Associate to lead and coordinate activities in the QC Bioanalytical Sciences laboratory at the manufacturing site. The role focuses on lab operations, compliance, continuous improvement projects, and acting as a role model for colleagues, with minimal supervision.

You will drive lean initiatives, support Right First Time goals, and represent the QC unit in interactions with customers and regulatory bodies, while contributing to procedure development and validation