What are the responsibilities and job description for the QC Systems Integration Consultant (GMP Laboratory Systems) position at Avacone?
We are seeking an experienced QC Systems Integration Consultant to support a large-scale migration and consolidation program across multiple GMP regulated Quality Control laboratory systems. This role is focused on the end to end implementation, integration coordination, and validation support of a complex laboratory IT and instrument landscape, ensuring compliant deployment and successful operational readiness.
The consultant will play a critical role in managing system onboarding, coordinating technical and business stakeholders, overseeing implementation progress, and supporting validation activities in close collaboration with QA and laboratory teams.
Key Responsibilities
- Lead implementation kick off activities for multiple QC laboratory systems within a GMP regulated environment
- Coordinate and oversee end to end system integrations across laboratory instruments, software applications, and enterprise platforms
- Manage project execution against agreed scope, timeline, budget, and quality objectives
- Drive alignment between laboratory operations, IT, vendors, QA, and validation stakeholders
- Monitor implementation progress, identify risks, and proactively resolve integration issues
- Support data migration and system consolidation activities across legacy and target platforms
- Ensure proper documentation and compliance with internal CSV / CSA and GxP requirements
- Support QA and validation teams during IQ / OQ / PQ execution
- Review validation deliverables, test evidence, deviations, and remediation actions
- Prepare systems for compliant go live and handover to operational support teams
Systems Landscape
Experience with several of the following systems is highly desirable:
- SingleLIMS
- ChemiDoc-IT2 Imager
- NuGenesis SDMS
- SDC
- ViCell Blu
- 32 Karat
- Security Administration / VISIONsecurity
- ZS Xplorer Software / OmniTrust / OmniTrail
- QX Manager GxP
- LMS Xchange
- SoftMax Pro GxP (including Admin) to gSMP
- Diomni
- QuantStudio Test Development Software
- WinKQCL
- Image Lab (ChemiDoc Gel Reader)
- gLabX
- Empower 3 Enterprise GMP to gEmpower
- Raw 2.0
- Strong experience in QC laboratory systems integration within GMP regulated environments
- Proven track record in implementation of laboratory instruments and associated software platforms
- Solid understanding of computer system validation, data integrity, and GxP compliance
- Experience supporting IQ / OQ / PQ activities in collaboration with QA
- Strong stakeholder management across laboratory, IT, quality, and vendor organizations
- Ability to manage multiple parallel workstreams in a complex program environment
- Excellent communication and coordination skills in cross functional teams
Preferred Background
- Experience in pharmaceutical, biotech, or life sciences environments
- Strong familiarity with QC laboratory workflows and analytical instruments
- Knowledge of regulated migration and system consolidation programs
Engagement Details
- Duration: 18 months
- Location: Preferred onsite in Philadelphia
- Working Model: Hybrid / travel model possible, for example onsite every second week