Quality Control Specialist IV – LIMS Administrator

Quality Control Specialist IV – LIMS Administrator

The LIMS Administration Specialist will drive the implementation, configuration, and sustained use of the Laboratory Information Management System (LIMS) to support GMP Quality Control (QC) testing. This role is critical to enabling digital transformation of QC workflows and ensuring compliant, efficient, and data-integrity-driven operations across the analytical testing lifecycle. The successful candidate will bring hands-on experience in GMP QC environments, with deep knowledge of laboratory workflows, regulatory requirements (e.g., 21 CFR Part 11, data integrity, ALCOA+), and technical expertise in LIMS configuration, SQL, and built-in reporting tools. This individual will collaborate closely with QC scientists, QA, IT, and LIMS vendors to ensure the system supports method execution, sample management, batch release testing, and audit readiness.

Responsibilities

• Lead and execute the end-to-end LIMS implementation for GMP QC testing, including system configuration, user acceptance testing (UAT), and validation.
• Configure LIMS workflows for sample receipt, testing, stability studies, method execution, batch release, and CoA generation, ensuring alignment with GMP QC operations, converting paper-based records into digital executable forms.
• Develop and maintain reporting tools to support routine QC reporting, trending, and batch release documentation.
• Write and optimize SQL queries to manage and analyze QC data from relational databases (e.g., SQL Server); ensure compliance with data integrity expectations.
• Collaborate with QC leads and QA to translate testing workflows, sample flows, and instrument integration needs into digital solutions.
• Develop and deliver role-based LIMS training for QC analysts, supervisors, and system administrators; maintain user access records and training documentation.
• Author and maintain LIMS-related documentation including User Requirements (URS), configuration specifications, SOPs, validation protocols (IQ/OQ/PQ), and change controls.
• Work closely with the Computer and Equipment Validation team to support validation activities per GAMP 5 principles; ensure system meets requirements for 21 CFR Part 11.
• Act as a QC data scientist by evaluating method variability and identifying potential biases introduced by associated instrumentation and software platforms (e.g., FlowJo, BD FACSuite), including both data acquisition and analysis workflows.
• Serve as a QC digital systems SME during audits and inspections; prepare and present system documentation and traceability matrices as needed.
• Drive continuous improvement initiatives to reduce manual data entry, streamline workflows, enhance right-first-time documentation, and improve turnaround times.

Qualifications

• Bachelor's degree or higher in Chemistry, Biology, or equivalent degree in a related science.
• 5+ years related experience within a relevant field, preferably biotechnology or cell therapy industry or equivalent combination of education and experience; 2+ years of LIMS configuration or administration experience (e.g., LabVantage, Element LIMS) is required; specific experience with L7 LIMS preferred.
• Previous experience implementing and administering training for LIMS required.
• Experience with bioinformatics tools, data pipelines, or structured programming (Python, DAX, Power Query M, VBA).
• Hands-on laboratory experience with cell-based, flow-cytometry based and/or molecular-based assays would be a plus.
• Demonstrated proficiency in Microsoft Excel, including formulas and expressions, and spreadsheet validation for GMP use.
• Strong understanding of GMP requirements, data integrity (ALCOA+ principles), and experience validating spreadsheets or digital systems.
• Excellent troubleshooting and analytical thinking skills; able to identify system issues and work cross-functionally to resolve them.
• Strong communication and documentation skills; ability to write and maintain SOPs and training materials.
• Capable of working independently in a fast-paced, regulated environment, including occasional flexible work hours to support manufacturing timelines.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Able to carry out planned activities with minimal supervision.
• Shows initiative to take on additional responsibility.
• Proficient with Microsoft Office (Excel, Outlook, etc.).

Base salary range: $95,000 - $105,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.