QC Lab Systems Implementation Consultant

QC Lab Systems Implementation Consultant

Work Location & Reporting Address: Philadelphia, PA 19103 (Onsite-Hybrid. Will consider candidates willing to relocate to client's location)

Must Have Skills: SingleLIMS, hemiDoc-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 (incl Admin) -> gSMP, Diomni, QuantStudio Test Development Software, WinKQCL, Image Lab (ChemiDoc Gel Reader), gLabX Empower 3 Enterprise - GMP -> gEmpower, Raw 2.0

Nice to Have Skills: A candidate whose background more closely aligns with laboratory instruments and systems is preferred.

Detailed Job Description: This work package prepares the active implementation of the developed plan. The objective is the on-time, on-budget, and high-quality implementation, validation, and go-live of the defined QC target systems based on the 4 packages (Implementation Kick-offs, Management and Oversight of Implementation, Continuous Progress Tracking, Support of Validation Activities) for each of the systems:

• 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 (incl Admin) -> gSMP
• Diomni
• QuantStudio Test Development Software
• WinKQCL
• Image Lab (ChemiDoc Gel Reader)
• gLabX
• Empower 3 Enterprise - GMP -> gEmpower
• Raw 2.0

Implementation Kick-offs:

• Activity: Conducting dedicated kick-off meetings before the start of each target system's implementation.
• Deliverable: A unified understanding, clear objectives, and binding commitment from all involved team members, subject matter experts, and users for their respective implementation phase.

Management and Oversight of Implementation:

• Activity: Actively managing and coordinating all technical and organizational implementation activities according to the project plan. This includes configuration, monitoring of master data migration, and steering of internal and external resources.
• Deliverable: The QC target systems are technically implemented and ready for the formal testing and validation phases.

Continuous Progress Tracking (Controlling):

• Activity: Persistent "Plan vs. Actual" comparison of project progress regarding schedule, cost, and scope/quality. Early identification of deviations and proactive initiation of corrective control measures.
• Deliverable: Transparent Progress Reports for management and stakeholders. Ensuring the project remains "on track" or that deviations are managed in a controlled manner.

Support of Validation Activities (Compliance):

• Activity: Providing functional and coordinative support to the Quality Assurance (QA) team during the planning, execution, and documentation of required validation steps (e.g., IQ/OQ/PQ).
• Deliverable: Successfully executed validation activities, which confirm compliance with internal (Roche) and external (e.g., GxP) regulations. This is the prerequisite for formal system acceptance and go-live.

Service Delivery & Project Management KPIs:

• Delivery Speed (Velocity) KPI: Sprint/PI Commitment Completion What it measures: The percentage of items (Main Objectives, Team Tasks) successfully delivered compared to what was planned. Target: 85% – 90% completion of committed backlog items per cycle.
• Quality of Execution (Defect Rate) KPI: Quality of Outcome What it measures: How many bugs or technical issues are found after the team says the work is done (e.g., during PQ runs or GMP phases). Target: Zero critical defects; < 5% minor issues.
• Efficiency (Turnaround Time) KPI: Average Lead Time for Change Requests What it measures: The total time from when a user submits a request (e.g., a new equipment integration) to when it is fully tested and ready for use. Target: Consistent reduction in weeks/days over the project duration.
• Reliability (First-Pass Success) KPI: Right-First-Time (RFT) Testing What it measures: The percentage of test cases or validation protocols that pass on the very first attempt without needing a "re-test" or software fix. Target: > 95% success rate for manual and automated tests.

Minimum Years of Experience: 5-8 years

Interview Process - Yes, face to face required