Senior QA Associate, PQA - 1st Shift (On-Site)

Regulatory Jobs; Holly Springs (NC); On-site; USD 82,000 - 111,000; Full time

Job summary

Amgen in the United States is seeking a Sr Associate Quality Assurance – PQA for 1st shift to support ongoing bulk drug substance manufacturing and new product introductions across development, clinical, and commercial operations.

You will facilitate real-time decisions to ensure GMP quality, coaching and directing manufacturing teams, and maintaining compliance with GDP and cGMP requirements. Staff are on-site with shift structures including late afternoons and nights.

Qualifications

• High school/GED with 4+ years in quality/manufacturing or regulated environment.
• Associate’s with 2+ years in quality/manufacturing or regulated environment.
• Bachelor’s with 6 months of relevant experience or higher.
• Master's degree in a related field.

Responsibilities

• Quality oversight of new product introduction across facilities, utilities, equipment, and systems.
• Review and approve deviations, CAPAs, change control, and validations.
• Ensure records comply with cGMP, GDP, and applicable regulations.
• Provide on-the-floor analytical testing guidance and issue investigations.
• Assist audits and inspections with regulatory agencies as needed.
• Drive continuous improvement within processes and systems.

Skills

cGMP knowledge

GDP knowledge

Biotech manufacturing

Education

High school/GED +4 years

Associate’s +2 years

Bachelor’s +6 months

Master's

Tools

Microsoft Office

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen in the United States is seeking a Sr Associate Quality Assurance – PQA for 1st shift to support ongoing bulk drug substance manufacturing and new product introductions across development, clinical, and commercial operations.

You will facilitate real-time decisions to ensure GMP quality, coaching and directing manufacturing teams, and maintaining compliance with GDP and cGMP requirements. Staff are on-site with shift structures including late afternoons and nights.