QA Lead on the Floor (Nights) – 12-Hour Shift

Amgen SA; West Greenwich (RI); In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Shift differential 15%

Total Rewards Plan

Flexible work model

Descrizione del lavoro

Amgen seeks a Sr Associate QA for Nights to provide on-the-floor quality assurance support during manufacturing operations. You will interact with Manufacturing, Quality Control, and Facilities/Engineering to ensure cGMP compliance and real-time quality decisions.

The role requires coaching, documentation, and adherence to quality systems, with a rotating 12-hour night shift (7 PM–7 AM) and an enhanced 15% shift differential.

Competenze

• High school/GED + 4 years Quality Assurance or manufacturing work experience
• Associate’s + 2 years Quality Assurance or manufacturing work experience
• Bachelor’s + 6 months Quality Assurance or manufacturing work experience
• Master's

Mansioni

• Provide Quality oversight to ensure products are manufactured, tested, stored, and distributed per cGMP and GDP regulations.
• Oversee on-the-floor analytical testing and ensure facilities, equipment, materials, and processes follow cGMP.
• Review and approve quality documents such as SOPs, batch records, deviations, and logbooks.
• Investigate and document deviations; ensure production records and testing results are complete and accurate.
• Provide coaching and direction to Manufacturing, Quality Control, and Facilities/Engineering staff on compliance and quality systems.
• Escalate potential quality or safety risks to senior management and drive process improvements.

Conoscenze

Quality Assurance

Manufacturing experience

Data integrity

Decision making

cGMP knowledge

Strumenti

Microsoft Office

Descrizione del lavoro

Amgen seeks a Sr Associate QA for Nights to provide on-the-floor quality assurance support during manufacturing operations. You will interact with Manufacturing, Quality Control, and Facilities/Engineering to ensure cGMP compliance and real-time quality decisions.

The role requires coaching, documentation, and adherence to quality systems, with a rotating 12-hour night shift (7 PM–7 AM) and an enhanced 15% shift differential.