Specialist PQA

Specialist PQA

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.

• 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 elevate 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.

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

• 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 skills
• A proactive, collaborative mindset with the ability to operate in a fast‑paced, evolving environment

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, which includes:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.