Senior Microbiology QC Specialist

Amgen; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental & Vision insurance

Stock-based incentives

Discretionary bonus program

Flexible work models

Job summary

Amgen in Puerto Rico is seeking a Sr. Associate Quality Control- Microbiology to join our team and help ensure the quality, safety, and consistency of our products before they reach patients.

You will perform critical analytical testing, maintain strict documentation, and act as a subject matter expert on cGMPs and SOPs while mentoring peers. The role may require non-standard shifts and collaboration across QA, manufacturing, and quality systems.

Qualifications

• Master’s Degree in Microbiology, Biotechnology, or related field.
• Experience or coursework in GMP environment.
• Written and oral communication skills in English and Spanish.
• Ability to understand and apply regulatory requirements.

Responsibilities

• Perform routine and advanced analytical testing with precision per SOPs.
• Maintain documentation in LIMS, CIMS, LMES with Good Documentation Practices.
• Serve as SME on cGMPs and SOPs; mentor peers.
• Troubleshoot testing issues and escalate as needed.
• Review lab results for accuracy and data integrity.
• Participate in method validation and verification activities.
• Manage samples with proper handling and tracking.
• Support continuous improvement and SOP revisions.
• Communicate results clearly to team and stakeholders.
• Prioritize tasks to meet deadlines and balance workload.

Skills

Bilingual English/Spanish

Project management

Strong organizational skills

Regulatory compliance knowledge

Technical writing skills

Quality testing expertise

Education

Master’s Degree

Bachelor’s Degree + 6 months Quality/Lab experience

Associate’s Degree + 2 years Quality/Lab experience

High school/GED + 4 years Quality/Lab experience

Job description

Amgen in Puerto Rico is seeking a Sr. Associate Quality Control- Microbiology to join our team and help ensure the quality, safety, and consistency of our products before they reach patients.

You will perform critical analytical testing, maintain strict documentation, and act as a subject matter expert on cGMPs and SOPs while mentoring peers. The role may require non-standard shifts and collaboration across QA, manufacturing, and quality systems.