Night QA Associate - On-the-Floor Quality

Amgen; West Greenwich (RI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible

Job summary

Amgen in the United States seeks a Sr Associate QA - Nights to provide on-the-floor quality assurance during bulk drug substance manufacturing, ensuring real-time compliance with cGMP, GDP and company procedures. The role collaborates with Manufacturing, Quality Control and Facilities/Engineering, coaching staff and driving deviations investigations.

The position operates a 12-hour night shift (7 PM to 7 AM) with a rotating schedule and an added 15% shift differential.

Qualifications

• High school/GED with 4 years QA/manufacturing experience or equivalent.
• Associate’s degree plus 2 years QA/manufacturing experience.
• Bachelor’s degree plus 6 months QA/manufacturing experience.
• Master's degree preferred for advanced roles.

Responsibilities

• Provide Quality oversight to ensure products are manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
• Provide Quality oversight during on-the-floor analytical testing.
• Ensure facilities, equipment, materials, processes, and procedures follow cGMP and regulations.
• Investigate and document deviations per procedures.
• Review and approve cGMP processes, SOPs, batch records, deviations, and logbooks.
• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.

Skills

Decision making

Analytical testing

Data integrity

Microsoft Office

Education

High school/GED

Associate’s degree

Bachelor’s degree

Master's

Tools

Microsoft Office

Job description

Amgen in the United States seeks a Sr Associate QA - Nights to provide on-the-floor quality assurance during bulk drug substance manufacturing, ensuring real-time compliance with cGMP, GDP and company procedures. The role collaborates with Manufacturing, Quality Control and Facilities/Engineering, coaching staff and driving deviations investigations.

The position operates a 12-hour night shift (7 PM to 7 AM) with a rotating schedule and an added 15% shift differential.