Senior QA Associate - 2nd Shift (GMP/Quality)

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

Job summary

Amgen is seeking a Sr Associate Quality Assurance I – PQA on second shift to collaborate with plant manufacturing and quality teams for ongoing GMP-compliant operations. You will help support bulk drug substance manufacturing, new product introductions, and real-time decision making to uphold quality standards.

The role involves coordinating deviations, CAPA, change controls, and regulatory interactions, with on-site shift structure and potential weekend coverage.

Qualifications

• High school/GED plus 4 years in 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

Responsibilities

• Support ANC facility commissioning and qualification and manufacturing Analytical Equipment Qualification and Validation activities.
• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process.
• Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and GDP.
• Drive closure of deviations, investigations, CAPA, change control and validations; ensure records are complete and compliant.
• Assist audits and interact with regulatory agencies during on-site inspections.

Skills

cGMP

GDP

Biotech

Plant startup

Quality systems

Education

HS/GED + 4 years

Associate's + 2 years

Bachelor's + 6 months

Master's

Tools

MS Office

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen is seeking a Sr Associate Quality Assurance I – PQA on second shift to collaborate with plant manufacturing and quality teams for ongoing GMP-compliant operations. You will help support bulk drug substance manufacturing, new product introductions, and real-time decision making to uphold quality standards.

The role involves coordinating deviations, CAPA, change controls, and regulatory interactions, with on-site shift structure and potential weekend coverage.