QC Systems Expert: LIMS, GMP & Data Integrity

Amgen; West Greenwich (RI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Retirement and savings plan

Job summary

Amgen is seeking a QC Specialist to support Quality Control laboratory systems, with primary responsibility for LIMS and related systems. You will ensure compliance with GMP, data integrity, and CSV expectations while aiding design, validation, and maintenance across the QC tech stack.

The role requires strong technical writing, cross‑functional collaboration, and experience with LIMS and validated lab systems. Amgen offers robust benefits and opportunities for professional growth.

Qualifications

• Doctorate, or equivalent, required for this QC role.
• 5+ years in pharmaceutical/biotech quality systems or QC.
• Experience with LIMS and validated laboratory systems preferred.

Responsibilities

• Serve as SME for QC systems and LIMS templating across labs.
• Support life‑cycle management: design, config, validation, maintenance.
• Ensure GMP, 21 CFR Part 11 compliance and data integrity.
• Configure and approve LIMS templates for samples and specs.
• Collaborate with Manufacturing, Process Development, Engineering, IT, and QA.

Skills

Analytical skills

Technical writing

Cross-functional collaboration

Communication

Presentation skills

Education

Doctorate degree

Master’s degree + 2 years quality experience

Bachelor’s degree + 4 years quality experience

Associate’s degree + 8 years quality experience

High school diploma + 10 years quality experience

Tools

Sample Manager LIMS

Empower

ELN/LMES

Veeva

Kneat

ALM

SQL

Reporting tools

Job description

Amgen is seeking a QC Specialist to support Quality Control laboratory systems, with primary responsibility for LIMS and related systems. You will ensure compliance with GMP, data integrity, and CSV expectations while aiding design, validation, and maintenance across the QC tech stack.

The role requires strong technical writing, cross‑functional collaboration, and experience with LIMS and validated lab systems. Amgen offers robust benefits and opportunities for professional growth.