Senior QA Associate, GMP Drug Product

Amgen SA; Thousand Oaks (CA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plan

Flexible work models

Stock-based incentives

Job summary

Amgen in Thousand Oaks seeks a Sr. Associate Quality Assurance to support the Plant QA organization, providing daily oversight of Drug Product manufacturing and ensuring processes, procedures, and quality systems meet regulatory requirements.

Duties include electronic batch review, GMP document revision, maintenance work order approvals, and evaluating deviations, with shifts to support 24/7 production in a clean room environment.

Qualifications

• GMP experience required based on educational level.
• Knowledge of SOPs and good documentation practices.
• Experience managing projects to meet timelines.
• Ability to evaluate documentation and operations per procedures.
• Experience with Quality Systems.
• Strong organization and multitasking.
• Effective written and verbal communication.
• Able to work as team player or independently.
• Leadership and drive for improvements.
• Understanding aseptic principles.

Responsibilities

• Presence on manufacturing floor during gowning and inspection.
• Electronic batch review.
• GMP document revision review/approval (SOPs/Forms).
• Review and approval of electronic maintenance documentation/work orders.
• Quality support and approval of minor deviations.
• Electronic Batch Record revisions and approvals.
• Evaluate compliance issues and progress of quality records.

Skills

GMP experience

Documentation

Quality systems

Communication

Leadership potential

Education

Bachelor's degree

Associate's degree

High school/GED

Master's degree

Tools

SOPs/FORMs

MES

Electronic batch records

Job description

Amgen in Thousand Oaks seeks a Sr. Associate Quality Assurance to support the Plant QA organization, providing daily oversight of Drug Product manufacturing and ensuring processes, procedures, and quality systems meet regulatory requirements.

Duties include electronic batch review, GMP document revision, maintenance work order approvals, and evaluating deviations, with shifts to support 24/7 production in a clean room environment.