GxP Quality Control Associate, Manufacturing

Amgen; West Greenwich (RI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Retirement plan

Discretionary bonus program

Stock-based incentives

Time-off plans

Flexible work model

Job summary

Amgen is seeking a QC for Manufacturing - Team B Associate Quality Control to perform microbiology testing and data management within a fast-paced GMP environment. You will handle sample collection, testing, documentation, and instrument operation while maintaining cGMP compliance.

The role requires a Bachelor’s degree or equivalent experience, with preferred background in GxP labs and experience with LIMS/Trackwise; strong attention to detail and teamwork are essential.

Qualifications

• Bachelor’s degree required OR Associate’s degree with 6 months quality experience OR High school/GED with 2 years quality experience.
• Experience in fast-paced GxP laboratory environments preferred.
• Experience executing test methods for microbiology (bioburden, endotoxin) preferred.

Responsibilities

• Perform sample collection and handling to support GMP operations and Environmental/Water monitoring.
• Perform testing and data review for microbiology and routine laboratory procedures.
• Operate and maintain laboratory equipment and instrumentation.
• Generate accurate laboratory documentation using electronic systems and notebooks.
• Maintain training compliance and ensure safety and regulatory guidelines are followed.

Skills

Quality control

GxP

Microbiology

LIMS

LMES

Trackwise

cGMPs

Regulatory compliance

Education

Bachelor's degree

Associate's degree

High school/GED

Tools

LIMS

LMES

CIMS

Trackwise

Job description

Amgen is seeking a QC for Manufacturing - Team B Associate Quality Control to perform microbiology testing and data management within a fast-paced GMP environment. You will handle sample collection, testing, documentation, and instrument operation while maintaining cGMP compliance.

The role requires a Bachelor’s degree or equivalent experience, with preferred background in GxP labs and experience with LIMS/Trackwise; strong attention to detail and teamwork are essential.