Senior QC Specialist (Lab Systems)

Lonza•Vacaville, CA

10d•$88,000 - $140,000

About The Position

Lonza Vacaville is seeking a QC Specialist to join the Quality Control team. The incumbent will drive governance, accuracy, and GMP-compliant management of QC laboratory systems, ensuring GxP data integrity and the seamless configuration of system master data. What you will get The full-time base annual salary for this position is expected to range between $88,000 to $140,000. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus Medical, dental and vision insurance 401(k) matching plan Life insurance, as well as short-term and long-term disability insurance Employee assistance programs Paid Time Off

Requirements

Bachelor’s degree in a scientific discipline (preferably Chemistry or relevant scientific discipline) with a minimum of 5 years of experience in a GMP or regulated environment, or an equivalent combination of education and experience.
Strong understanding of computerized systems used in QC (e.g., LIMS) and associated data integrity principles.
Effective communication and collaboration with customers and teams.
Ability to independently assess and resolve system issues using a risk‑based approach.
Proficiency in system configuration, master data management, and controlled system changes.
Strong analytical and troubleshooting skills to identify root causes of system or data issues.
Strong documentation skills to support audits, inspections, and system lifecycle records.

Responsibilities

Owns the configuration and maintenance of QC laboratory system master data (e.g., LIMS) to ensure data accuracy, traceability, and compliance with GMP and data integrity requirements.
Independently diagnoses and resolves complex lab system issues, determining appropriate corrective actions or workarounds, escalating only when issues exceed defined system governance or risk thresholds.
Acts as the QC Systems technical owner for assigned initiatives, including system readiness for tech transfers, changes, and enhancements, ensuring laboratory systems are production ready and aligned with business timelines.
Leads execution of system related documentation and procedural activities, including development, review, and maintenance of SOPs and work instructions to support compliant and standardized operations.
Provides subject matter expertise during deviations, investigations, and CAPAs related to laboratory systems, contributing to root cause analysis, risk assessment, and implementation of sustainable corrective actions.
Supports audit and inspection activities as a system subject matter expert, preparing documentation, responding to auditor inquiries, and presenting system controls and data flows as required.
Identifies opportunities for system and process improvements and implements enhancements within defined quality and change management frameworks.