Job Description

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
We have a great opportunity as a LIMS Analyst at our site in Northridge. This individual will be responsible for the administration, governance, and strategic oversight of the Laboratory Information Management System (LIMS) within the Quality Control organization. This role supports business operations by ensuring the system aligns with regulatory requirements, data integrity standards, and operational needs. This role serves as a key liaison between Quality, IT, and cross-functional stakeholders, driving continuous improvement and ensuring that LIMS capabilities support business objectives in a cGMP-regulated environment.
Role Responsibilities:
• Oversee and govern the LIMS platform, including system configuration, data structures, user access protocols, and workflow design to ensure alignment with regulatory and business requirements
• Exercise independent judgment in evaluating, approving, and implementing system changes, enhancements, and process improvements that impact laboratory operations and compliance
• Design and optimize workflows within LIMS to support efficiency, scalability, and adherence to cGMP and data integrity requirements.
• Interpret regulatory expectations (e.g., FDA, ISO) and translate them into system requirements, ensuring LIMS configurations support audit readiness and inspection outcomes.
• Lead investigations into system-related deviations, data discrepancies, or compliance risks, determining root cause and implementing corrective actions.
• Serve as the primary subject matter expert (SME) for LIMS, providing guidance to management and cross-functional teams on system capabilities, limitations, and business implications.
• Collaborate with IT and Quality leadership to prioritize and implement system enhancements, balancing operational needs with compliance and risk considerations.
• Monitor system performance and data trends, proactively identifying areas for improvement and implementing solutions to enhance reliability and business outcomes.
• Develop and maintain policies, procedures, and governance standards for LIMS usage, ensuring consistency and adherence across the organization.
• Provide training and strategic guidance to laboratory personnel, ensuring effective use of LIMS and alignment with established processes and compliance expectations.
Required Skills and Experience:
• Bachelor’s degree in a scientific, technical, or related field.
• 3+ years of experience in a Quality Control or regulated laboratory environment
• Experience administering or supporting LIMS or comparable enterprise systems
• Strong understanding of cGMP, data integrity principles, and regulatory expectations
• Demonstrated ability to analyze complex problems, exercise independent judgment, and implement solutions
• Strong communication and collaboration skills with the ability to influence cross-functional stakeholders
Preferred Skills and Experience
• Experience with StarLIMS or similar platforms
• Experience leading systems improvement, validation activities or audit support efforts
• Knowledge of FDA, ISO, and other applicable regulatory frameworks impacting laboratory systems
• Ability to work on cross-functional and global teams
• Excellent project management and problem-solving skills
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The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

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Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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