Senior QC Chemist – Startup, Validation & Transfers

Amgen Inc.; Holly Springs (NC); On-site; USD 79,000 - 107,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary bonus

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen Inc. in Holly Springs, NC, seeks a SR Associate Quality Control I to join the QAQC team. You will support the Chemistry lab startup, qualification, and routine testing to back our Holly Springs facility, writing procedures and validating systems.

The role requires hands-on QC chemistry experience in GMP settings, with emphasis on method transfers, data integrity, and collaboration across departments. Eligible candidates should have strong communication skills and readiness for diverse lab

Qualifications

• 4+ years of relevant laboratory experience in GMP commercial manufacturing environment.
• Strong knowledge of laboratory techniques.
• Experience with equipment validation, transfer and method validation including change controls.

Responsibilities

• Support Chemistry lab startup and qualification activities, including equipment installation, qualification, and validation.
• Write procedures and reports; assist with data integrity assessments and computerized system onboarding.
• Lead start-up activities for QC Chemistry, including system qualification and method transfer; support CAPA and change control processes.
• Collaborate with site teams to establish work orders and PM system for laboratory equipment; assist audits and cross-functional projects.

Skills

Lab techniques

Quality control

Documentation

Data integrity

Written communication

Education

Bachelor's degree in Chemistry/Biochemistry/Physics or Chemical Engineering

Tools

LIMS

LMES/CIMS

Job description

Amgen Inc. in Holly Springs, NC, seeks a SR Associate Quality Control I to join the QAQC team. You will support the Chemistry lab startup, qualification, and routine testing to back our Holly Springs facility, writing procedures and validating systems.

The role requires hands-on QC chemistry experience in GMP settings, with emphasis on method transfers, data integrity, and collaboration across departments. Eligible candidates should have strong communication skills and readiness for diverse lab