Senior QA On‑Floor Lead (PQA) — Night Shift

1001 Amgen Inc.; Holly Springs (NC); On-site; USD 82,000 - 111,000; Full time

Job summary

Amgen Inc. in North Carolina is seeking a Senior Associate Quality Assurance (PQA) for on-floor, night-shift support of bulk drug substance manufacturing and new product introductions. You’ll ensure real-time quality decisions, coach manufacturing staff, and partner with regulatory-ready processes on-site.

The role emphasizes cGMP compliance, GDP adherence, and deviation management within a 24/7 operation. Strong collaboration, documentation, and problem-solving are essential for success.

Qualifications

• High school/GED with 4 years QA/manufacturing or regulated work experience.
• Associate’s degree plus 2 years QA/manufacturing or regulated experience.
• Bachelor’s degree plus 6 months QA/manufacturing or regulated experience.
• Master’s degree in a related field or higher.

Responsibilities

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems.
• Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP and other regulations.
• Ensure facilities, equipment, materials, organization, processes, and procedures comply with regulations and Amgen requirements.
• Drive closure of cGMP processes, procedures, documents, records including deviations, investigations, CAPAs, change controls, validations.
• Ensure production and testing records are complete, accurate, and documented per procedures and GDP/cGMP.
• Oversee and provide guidance during on-floor analytical testing.
• Identify and implement improvements to prevent quality issues.
• Support audits and inspections; may interact with regulators on-site.

Skills

cGMP awareness

GDP practices

Regulatory awareness

Quality oversight

Project coordination

Education

High school/GED + 4 years QA/regulatory experience

Associate’s + 2 years QA/regulatory experience

Bachelor’s + 6 months QA/regulatory experience

Master’s

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen Inc. in North Carolina is seeking a Senior Associate Quality Assurance (PQA) for on-floor, night-shift support of bulk drug substance manufacturing and new product introductions. You’ll ensure real-time quality decisions, coach manufacturing staff, and partner with regulatory-ready processes on-site.

The role emphasizes cGMP compliance, GDP adherence, and deviation management within a 24/7 operation. Strong collaboration, documentation, and problem-solving are essential for success.