Sr Associate QA

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. In this vital role, you will ensure that operations products are manufactured, tested, stored, and distributed according to Good Manufacturing Practices (cGMP).

Responsibilities

• Supports and audits inspection preparation, planning, execution, and response activities, as well as facilitating completion of compliance and regulatory requests.
• Provides QA oversight for IQA and ensures area readiness as the IQA compliance representative.
• Supports IQA quality events, change controls, and risk assessments.
• Supports ATO Management Review activities and metric control plan adherence.
• Performs review, approval, and tracking of cGMP processes, procedures, assays, documents, and records, including but not limited to Nonconformances, CAPAs, Change Control records, and validations. May also support execution of these tasks.
• Collaborates cross-functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
• Supports Continual Improvement initiatives, programs, and projects.
• Alerts management of quality, compliance, supply, and safety risks.
• Represents Quality Assurance during audits and inspections.
• Completes required assigned training to permit execution of required tasks.
• Responsible for complying with Good Manufacturing Practices and Good Documentation Practices.

Requirements

Basic Qualifications

• High school/GED + 4 years of Quality Assurance work experience
• Associate’s degree + 2 years of Quality Assurance work experience
• Bachelor’s degree + 6 months of Quality Assurance work experience
• Master’s degree

Preferred Qualifications

• Demonstrated knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations.
• Experience with Quality Management System (QMS) processes.
• Knowledge of quality metrics, Management Review processes, and continuous improvement methodologies.
• Experience supporting regulatory inspections, partner audits, and internal quality audits.
• Experience serving as a Quality Assurance representative within a manufacturing or quality organization.
• Excellent written and verbal communication skills, including the ability to present information to leadership and regulatory inspectors.

Benefits

Amgen offers a comprehensive employee benefits package, including:

• A Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.