Quality Control System/Equipment Specialist

Summary

The QC Equipment and System Specialist plays a key role in supporting and maintaining Quality Control (QC) equipment and systems, with an emphasis on Laboratory Information Management Systems (LIMS) and associated analytical software tools, QC equipment selection, qualification and lifecycle management and computerized systems methods. 

The position involves cross-functional collaboration with QC, QA, and IT, and global stakeholders to ensure data integrity, system compliance, and operational efficiency. The role requires deep expertise in QC equipment and associated softwares, LIMS QC processes implementation (preferably LabWare), strong project coordination skills, and the ability to translate QC user needs into effective technical solutions. The QC System Specialist drives system validation, process improvements, report customization, and contributes to new equipment implementation and data lifecycle management.

Key Responsibilities

• Lead QC equipment selection via URS creation, support equipment qualification and lifecycle management and interface with internal stakeholders (Quality operations, Engineering, Calibration/Qualification). 
• Coordinate with LIMS administrators and global teams to support system enhancements, issue resolution, and UAT reviews.
• Act as a key contributor in LIMS-related projects including new equipment and software implementations (Empower, SoftmaxPro, SoloVPE, …), from requirement gathering to technical execution and validation.
• Lead or support validation of computerized systems including URS creation, protocol development, execution, and compliance documentation.
• Create, manage and maintain computerized systems methods and protocols. 
• Actively lead and participate to QC digital/computerized projects and improvement (e.g. Custom Fields validation, Excel file validation)
• Interface with digital reporting systems (e.g., Power BI, MES/Skyland) to support integration and data visualization needs.
• Manage and maintain reports and templates within LIMS and related software to meet QC operational needs.
• Support deviation investigations, change control (CC), and GxP documentation updates related to QC computerized systems.
• Drive implementation of streamlined new processes within LIMS according to project timelines.
• Ensure compliance of LIMS UAT processes and configuration changes.
• Liaise with stakeholders (QA, QC, IT, vendors) to ensure cross-functional alignment on system functionalities and regulatory compliance.
• Act as the QC system SME during internal and external audits, providing technical documentation and explanations.
• Proactively identify system improvement opportunities and lead corrective/preventive actions related to QC systems.

Education and Experience

• Bachelor's or Master’s degree in life sciences, IT, bioinformatics, or engineering.
• 5-10 years of experience in the biotechnology or pharmaceutical industry in a GMP-regulated environment.
• Proven hands-on experience with LIMS (preferably LabWare) and analytical software (Empower, SoftmaxPro, SoloVPE, etc.).
• Experience in system validation, project coordination, and regulatory compliance.

Knowledge, Skills, Abilities

• Strong expertise in LIMS administration, technical configuration, and validation.
• Strong expertise in QC computerized systems (e.g., Empower, SoftMaxPro)
• Solid understanding of GMP guidelines, data integrity, and computerized system validation (CSV).
• Excellent project coordination skills, especially in cross-functional environments (QC, QA, IT).
• Strong communication skills in English (written and spoken); ability to collaborate with US-based teams.
• Technical problem-solving mindset, capable of translating user requirements into structured technical solutions.
• Proactive, self-driven, and comfortable taking ownership of complex topics.
• Strong leadership capabilities to drive system-related initiatives, report on progress, and influence stakeholders.
• Ability to manage multiple priorities while maintaining attention to detail and compliance.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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