Senior QC Chemistry Lead—Startup & Validation Expert

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

Benefits offered by this job

Comprehensive retirement plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Stock-based incentives

Generous paid time off

Flexible work models

Job summary

Amgen in the United States is seeking a Senior Associate Quality Control I to support the Holly Springs facility. You will lead QC Chemistry startup activities, qualify and validate systems, perform method transfers, and collaborate on data integrity assessments.

The role involves writing procedures, supporting equipment onboarding, and coordinating training and change control processes. Qualified candidates will have GMP lab experience, knowledge of analytical techniques, and strong technical

Qualifications

• 4+ years of relevant laboratory experience in GMP manufacturing environment.
• Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
• Experience with equipment and method validation, verification, and transfer.

Responsibilities

• Lead QC Chemistry startup activities including system qualification and validation and method transfers.
• Collaborate with site teams to establish work order and PM system for laboratory equipment.
• Review validation documents to support equipment and computerized system onboarding.
• Create and collaborate on Data Integrity Assessments for computerized lab systems.
• Author, revise and review SOPs, test methods, safety assessments, trend reports, qualification/validation reports, and technical assessments.
• Assist with procurement for consumables and critical reagents.
• Ensure training and method transfer for HPLC, UPLC, TOC and related bench-top equipment.
• Own Deviation, CAPA and Change Control records; participate in audits and interdepartmental projects.

Skills

Laboratory techniques

LIMS/LMES-CIMS

Regulatory compliance

Technical writing

Teamwork

Validation & transfer

Education

Bachelor's degree

Associate's degree

Master's degree

Tools

LIMS

LMES/CIMS

Job description

Amgen in the United States is seeking a Senior Associate Quality Control I to support the Holly Springs facility. You will lead QC Chemistry startup activities, qualify and validate systems, perform method transfers, and collaborate on data integrity assessments.

The role involves writing procedures, supporting equipment onboarding, and coordinating training and change control processes. Qualified candidates will have GMP lab experience, knowledge of analytical techniques, and strong technical