Specialist PQA

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist PQA

What you will do

Let’s do this. Let’s change the world. Amgen is expanding and with that comes an exciting opportunity to help build and strengthen quality systems that will support the next generation of packaging operations.

We’re seeking a QA Specialist to play a pivotal role in our B2 expansion, supporting Commissioning & Qualification (C&Q) and New Product Introduction (NPI) while ensuring our quality systems are robust, compliant, and inspection-ready from day one.

If you’re passionate about quality, thrive in building and improving systems, and want to be part of something new and impactful—this is your moment.

In this role, you will focus on strengthening and executing core Quality Systems while supporting startup and operational readiness:

• Provide QA support for Commissioning & Qualification (C&Q) activities, including review/approval of protocols and reports
• Actively support New Product Introduction (NPI) to ensure quality requirements are embedded from early stages through commercialization
• Lead and support Quality Systems processes, including:
  • Deviations
  • Product Disposition
  • CAPAs
  • Change Controls

• Ensure timely, thorough, and compliant investigations, driving effective root cause analysis and sustainable solutions
• Support batch disposition activities in alignment with packaging operations and quality requirements
• Partner with cross-functional teams to ensure quality systems are effectively implemented during B2 startup and ramp-up
• Drive and contribute to Continuous Improvement (CI) initiatives to enhance quality system performance and efficiency
• Ensure that changes impacting product quality are appropriately assessed and implemented through Change Control processes
• Maintain inspection readiness and support internal/external audits and regulatory inspections
• Identify and escalate quality and compliance risks
• Collaborate closely with Packaging, Engineering, PD, Supply Chain, and QC to ensure seamless execution

Position will train on first shift and then move to a shift structure. Possible shifts are 12 hour am, 12 hour pm, second or third shift, and/or one weekend day.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 2 years of Quality experience

OR

Bachelor’s degree and 4 years of Quality experience

OR

Associate’s degree and 8 years Quality experience

OR

High school diploma / GED and 10 years Quality experience

Preferred Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 3+ years of experience in Quality Assurance within a GMP-regulated environment
• Strong experience in Quality Systems (deviations, CAPA, change control, disposition)
• Experience supporting C&Q, validation, or startup activities highly preferred
• Experience with New Product Introduction (NPI) in a regulated environment is a strong plus
• Knowledge of cGMP and GDP requirements, with packaging experience preferred
• Ability to work flexible shifts as operations ramp up
• Strong analytical, problem-solving, and organizational