Sr Associate QA - Days

Join Amgen’s mission of serving patients. At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve pioneered the world of biotech in our fight against tough diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients annually. Amgen is advancing a broad pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As part of the Amgen team, you’ll help make a lasting impact on patients' lives through research, manufacturing, and delivering innovative medicines.

About the role

In this role, you will provide Plant Quality Assurance (PQA) on-the-floor support for Manufacturing activities. You’ll work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This position fosters collaboration between Manufacturing and Quality teams, offering coaching, guidance, and direction on compliance and quality systems.

Responsibilities

• Provide Quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP, and other applicable regulations.
• Oversee on-the-floor analytical testing.
• Ensure facilities, equipment, materials, processes, and procedures comply with cGMPs and other regulations.
• Investigate and document deviations from established procedures.
• Ensure production records and testing results are complete, accurate, and documented per cGMP requirements.
• Review and approve cGMP processes, procedures, and records, including 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.
• Alert senior management of potential quality, compliance, supply, or safety risks.
• Complete assigned training to execute required tasks.
• Drive operational improvement initiatives, programs, and projects.
• Perform additional tasks to support group, departmental, and company goals.

Requirements

Basic Qualifications:

• High school diploma/GED + 4 years of Quality Assurance or manufacturing experience, OR
• Associate’s degree + 2 years of Quality Assurance or manufacturing experience, OR
• Bachelor’s degree + 6 months of Quality Assurance or manufacturing experience.

Qualifications

Preferred Qualifications:

• Experience working in a cGMP environment.
• Decision-making experience.
• Experience with analytical testing and/or general compendia testing.
• Experience working with batch records and other GMP documentation.
• Knowledge of data integrity requirements.
• Proficiency in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams).

Benefits

Amgen supports your professional and personal growth with a competitive benefits package and collaborative culture. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted, with actual salary varying based on skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan, including:

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

Amgen is an Equal Opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. Individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.