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Specialist PQA

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Amgen

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Location:
United States , New Albany

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

104287.35 - 141094.65 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
April 22, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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