Senior QA PQA Specialist - 1st Shift

Amgen Inc.; Holly Springs (NC); On-site; USD 82,000 - 111,000; Full time

Benefits offered by this job

Retirement plan

Medical insurance

Vision and dental coverage

Disability insurance

Bonus program

Stock-based incentives

Flexible work options

Job summary

Amgen Inc. is seeking a Sr Associate Quality Assurance for the PQA team to ensure real-time quality oversight across manufacturing and new product introduction activities.

The role focuses on coaching, compliance, and collaboration between Manufacturing and Quality groups to uphold cGMP standards. The position requires shift flexibility, including late afternoons and nights, and offers opportunities within a leading biotechnology environment with a strong focus on patient impact.

Qualifications

• Experience in quality, manufacturing and regulated environments is required.
• Knowledge of cGMP and GDP behaviors is preferred.
• Experience supporting GMP testing laboratories is advantageous.
• Strong organizational skills with the ability to manage multiple tasks and meet deadlines.

Responsibilities

• Staff for the PQA team on-site.
• Support 24/7 operations and shift transitions (including late afternoons and nights).
• Provide quality oversight for new product introduction, deviations, CAPA, change control, and validations.
• Collaborate with Manufacturing and Quality to ensure compliance and timely task completion.

Education

High school/GED + 4 years of Quality, manufacturing and/or other regulated environment work experience

Associate’s + 2 years of Quality, manufacturing and/or other regulated environment work experience

Bachelor’s + 6 months of Quality, manufacturing and/or other regulated environment work experience

Master’s

Tools

Microsoft Office

EBR/MES

Delta V

Electronic Quality Systems

Job description

Amgen Inc. is seeking a Sr Associate Quality Assurance for the PQA team to ensure real-time quality oversight across manufacturing and new product introduction activities.

The role focuses on coaching, compliance, and collaboration between Manufacturing and Quality groups to uphold cGMP standards. The position requires shift flexibility, including late afternoons and nights, and offers opportunities within a leading biotechnology environment with a strong focus on patient impact.