QC Lab Systems Analyst

BioSpace; Pleasant Prairie (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Company Bonus

401(k)

Pension

Vacation Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Prescription Drug Benefits

Flexible Spending Accounts

Life Insurance

Death Benefits

Leave Benefits

Employee Assistance Program

Fitness Benefits

Employee Clubs and Activities

Job summary

BioSpace is seeking an experienced QC Lab Systems Specialist to design, configure, integrate, and support LIMS and chromatography data systems, ensuring reliable operations and timely batch release. You will lead system validation, lifecycle management, and complex issue resolution while mentoring the site’s lab systems workstreams.

The role requires a bachelor’s degree in a relevant field and at least five years of GMP-regulated QC systems experience; a master’s degree is preferred.

Qualifications

• A bachelor’s degree in a relevant technical or scientific field and at least five years of experience implementing or supporting QC laboratory systems in a GMP-regulated industry are required.
• A master’s degree and experience with the listed platforms and integrations are preferred.

Responsibilities

• Design, configure, integrate, and support QC laboratory systems, including LIMS, chromatography data systems, and instrument integrations, while ensuring reliable operations and timely batch release.

Skills

LIMS Configuration

Chromatography Data Systems

Laboratory Instrument Integration

Computer System Validation

GMP Compliance

Data Integrity

QC Laboratory Workflows

System Lifecycle Management

Incident and Change Management

Root Cause Analysis

Risk-Based Validation

Technical Leadership

Stakeholder Collaboration

SQL

Python

Cybersecurity

Education

Bachelor’s degree in a relevant field

Master’s degree preferred

Tools

LIMS

CDS

SQL

Python

Cybersecurity

Job description

Design, configure, integrate, and support QC laboratory systems, including LIMS, chromatography data systems, and instrument integrations, while ensuring reliable operations and timely batch release. Lead system validation, compliance, lifecycle management, complex issue resolution, continuous improvement, and technical mentoring for the site’s lab systems workstreams.

Requirements

A bachelor’s degree in a relevant technical or scientific field and at least five years of experience implementing or supporting QC laboratory systems in a GMP-regulated industry are required. Candidates need hands‑on experience with a commercial LIMS or CDS, knowledge of regulatory and data‑integrity requirements, and a strong understanding of QC laboratory processes; a master’s degree and experience with the listed platforms and integrations are preferred.

Key Skills

• LIMS Configuration and Support
• Chromatography Data Systems
• Laboratory Instrument Integration
• Computer System Validation
• GMP Compliance
• Data Integrity
• QC Laboratory Workflows
• System Lifecycle Management
• Incident and Change Management
• Root Cause Analysis
• Risk‑Based Validation
• Technical Leadership and Mentoring
• Stakeholder Collaboration
• SQL
• Python
• Cybersecurity

Benefits

• Company Bonus
• 401(k)
• Pension
• Vacation Benefits
• Medical Insurance
• Dental Insurance
• Vision Insurance
• Prescription Drug Benefits
• Flexible Spending Accounts
• Life Insurance
• Death Benefits
• Leave Benefits
• Employee Assistance Program
• Fitness Benefits
• Employee Clubs and Activities