Position:
QC Systems Consultant
Location:
Remote/Hybrid – Supporting a rapidly growing biotech manufacturing facility.
About Our Client
Our client is a dynamic and innovative biomanufacturing organisation at the forefront of producing clinical-stage materials. As their portfolio expands, this role will be critical in enhancing and maintaining their Quality Control (QC) laboratory systems, ensuring data integrity, operational efficiency, and regulatory compliance in a rapidly evolving environment.
The Role
The QC Systems Consultant will play a strategic and technical role in advancing the functionality and integration of QC laboratory data systems. This includes working with LIMS, analytical software platforms such as Empower and SoftMaxPro, and Excel-based tools. This high-impact position offers the chance to shape QC operations and contribute to the successful delivery of clinical-stage biomanufacturing projects.
Key Responsibilities
LIMS Coordination and Support
- Collaborate with internal LIMS teams and external vendors to configure and optimise LIMS functionality.
- Conduct user acceptance testing (UAT) to ensure LIMS compliance with regulatory standards and internal requirements.
- Oversee updates to LIMS reports, including environmental monitoring (EM) and QC data outputs, ensuring accuracy and usability.
Enhancement of Existing Software Systems
- Provide technical expertise for Empower and SoftMaxPro, developing and refining analytical methods and reports.
- Validate and manage Excel-based data handling tools, ensuring compliance with User Requirement Specifications (URS) and executing test protocols.
- Ensure GxP compliance for all validated systems and documentation.
Integration of New Equipment & Software
- Lead the integration of new laboratory equipment into QC workflows, including software setup and validation.
- Develop and execute validation protocols to ensure equipment reliability and compliance.
- Conduct periodic reviews and Data Accuracy Tests (DAT) for new systems.
Clinical Phase Implementation Support
- Streamline workflows for clinical Phase I materials, including sample management, stability scheduling, and Certificate of Analysis (CoA) generation.
- Enhance QC equipment reports to meet clinical-phase testing demands and improve data visibility.
Operational and Compliance Support
- Support quality events such as deviations, change controls (CC), and batch monitoring.
- Configure LIMS settings to standardise deviation closure formatting.
- Validate Empower custom fields and guide QC teams through execution and review phases.
Data Visualisation & System Interfaces
- Facilitate LIMS integration with enterprise systems, such as Power BI and Manufacturing Execution Systems (MES).
- Enable efficient data flow to improve decision-making processes for stakeholders.
Burning Topics & High-Priority Initiatives
- LIMS UAT: Conduct evidence verification for new functionalities.
- Deviation Closure Configuration: Implement and validate numeric field settings in LIMS.
- Empower Customisation: Coordinate with Waters for custom field validations.
- Excel Validation: Manage the life cycle of Excel validation protocols.
Qualifications & Skills
- Strong knowledge of Quality Management Principles (QMP), GMP, and regulatory frameworks relevant to biomanufacturing and QC laboratories.
- Proven experience with LIMS configuration, user testing, and validation.
- Expertise with analytical software platforms such as Empower and SoftMaxPro.
- Proficiency in Excel-based tools with experience in GxP-compliant spreadsheet validation.
- Excellent communication and project management skills for cross-functional collaboration.
- Adaptability in a dynamic environment, supporting the introduction of new molecules and clinical-stage processes.
What Makes This Role Unique?
- Strategic Impact: Shape the QC systems of a high-growth biotech.
- Innovation-Driven Environment: Collaborate on cutting-edge clinical-stage projects.
- Leadership Opportunities: Drive systems integration and process optimisation.
If this role aligns with your expertise, we encourage you to explore this exciting opportunity with us.
