Night QA Associate — On-the-Floor GMP Quality

BioSpace; West Greenwich (RI); On-site; USD 90,000 - 130,000; Full time

Job summary

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

This role requires rotating 12-hour shifts (7 PM–7 AM) with weekend rotation and a 15% shift differential; candidates should have QA/manufacturing experience and education per the basic qualifications.

Qualifications

• Bachelor's or higher degree in a related field or equivalent combination of education and experience.
• 4+ years QA or manufacturing experience for High School/GED path or 1+ year with a Bachelor’s.
• Experience in a cGMP environment preferred.
• Experience with batch records and GMP documentation is desirable.

Responsibilities

• Provide QA oversight to ensure products are manufactured, tested, stored, and distributed per cGMP/GDP and applicable regs.
• Oversee on-the-floor analytical testing and real-time quality decision-making.
• Ensure facilities, equipment, materials, processes, and procedures follow cGMP and regulatory requirements.
• Investigate and document deviations from procedures per written SOPs and cGMP.
• Review and approve cGMP processes, procedures, records, SOPs, batch records, deviations, and logbooks.
• Author and approve quality documents such as risk assessments and training materials.
• Escalate potential quality, compliance, or safety risks to senior management.
• Complete required training and drive continuous improvement initiatives.

Skills

Quality Assurance

Analytical thinking

Cross-functional collaboration

Education

High School/GED

Associates

Bachelors

Master's

Tools

Microsoft Office

Excel

PowerPoint

MS Teams

Job description

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

This role requires rotating 12-hour shifts (7 PM–7 AM) with weekend rotation and a 15% shift differential; candidates should have QA/manufacturing experience and education per the basic qualifications.