QC Systems SME - Lab Data & Compliance Leader

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

Benefits offered by this job

Retirement plan

Stock options

Flexible work models

Job summary

Amgen is seeking a QC Systems Specialist to serve as the Quality Control Systems SME for LIMS and related laboratory software. You will manage lifecycle activities—design, configuration, validation, maintenance, upgrades, and retirement—while ensuring GMP compliance and data integrity.

You will configure templates, support deployment of new functionality, and provide technical guidance to QC laboratories. This role requires strong analytical skills, cross-functional collaboration, and a

Qualifications

• Doctorate or higher in a relevant field or equivalent experience in pharmaceutical quality systems.
• Experience with GMP regulations, 21 CFR Part 11, and data integrity principles.
• Proven ability to author SOPs, validation documentation, and work instructions.
• Experience with LIMS, QC data management, and laboratory analytics.
• Strong written and verbal communication, plus cross-functional collaboration.

Responsibilities

• Serve as the QC Systems SME for LIMS and related laboratory systems.
• Manage lifecycle of laboratory systems including validation, upgrades, and retirement.
• Maintain compliance with GMP and regulatory requirements across systems.
• Configure LIMS templates for sample plans, specs, and metrics.
• Support deployment of QC systems and data retrieval/reporting across shifts.
• Provide technical support to QC labs to meet business needs and regulatory expectations.
• Lead and mentor users on QC systems and best practices.

Skills

GMP knowledge

Quality systems

Lab data analytics

SQL

SOP writing

Cross-functional collaboration

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma/GED

Tools

Sample Manager LIMS

Empower

ELN/LMES

Veeva

Kneat

ALM

Job description

Amgen is seeking a QC Systems Specialist to serve as the Quality Control Systems SME for LIMS and related laboratory software. You will manage lifecycle activities—design, configuration, validation, maintenance, upgrades, and retirement—while ensuring GMP compliance and data integrity.

You will configure templates, support deployment of new functionality, and provide technical guidance to QC laboratories. This role requires strong analytical skills, cross-functional collaboration, and a