QC Chemistry Analyst – Startup & Validation

Amgen Inc.; Holly Springs (NC); On-site; USD 63,000 - 85,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Medical/dental/vision coverage

Retirement plan

Job summary

Amgen Inc. in Holly Springs, NC, is seeking an Associate QC I to support the Chemistry lab start-up, qualification, and routine testing. You will help with system qualification, method transfers, data integrity, and GMP compliance while collaborating with cross-functional teams.

The role may require extended hours and weekend work as needed; a strong background in analytical chemistry and GMP manufacturing is essential for success.

Qualifications

• 4+ years lab experience in GMP pharma/manufacturing with analytical testing.
• Strong knowledge of laboratory techniques.
• Proficient with LIMS/LMES/CIMS.
• Familiar with regulatory and compliance issues.
• Strong written and verbal communication, technical writing.
• Experience with method validation, verification and transfers.
• Ability to work well in cross-functional teams.

Responsibilities

• Participate in QC Chemistry start-up activities including system qualification/validation and method transfers.
• Collaborate with site teams to establish work orders and PM for lab equipment.
• Assist with Data Integrity Assessments for computerized lab systems.
• Review and approve QC method executions for GMP and stability support.
• Assist with procurement of consumables and reagents.
• Ensure execution of method transfer for HPLC, UPLC, TOC and related equipment.
• Support audits, initiatives, and interdepartmental projects.
• Support weekend and holiday work as required.

Skills

GMP manufacturing experience

Analytical testing

Laboratory techniques

LIMS/LMES/CIMS

Communication skills

Education

Bachelor's degree in a related scientific field

Associate degree or higher

Tools

HPLC/UPLC

TOC

Lab equipment and instrumentation

Job description

Amgen Inc. in Holly Springs, NC, is seeking an Associate QC I to support the Chemistry lab start-up, qualification, and routine testing. You will help with system qualification, method transfers, data integrity, and GMP compliance while collaborating with cross-functional teams.

The role may require extended hours and weekend work as needed; a strong background in analytical chemistry and GMP manufacturing is essential for success.