Quality Control LIMS Analyst

Role Responsibilities

• Oversight and governance of the LIMS platform, including system configuration, data structures, user access protocols, and workflow design.
• Evaluate, approve, and implement system changes, enhancements, and process improvements.
• Interpret regulatory expectations and translate them into system requirements.
• Lead investigations into system-related deviations, data discrepancies, or compliance risks.
• Develop and maintain policies, procedures, and governance standards for LIMS usage.
• Provide training and strategic guidance to laboratory personnel.

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 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.
• Experience working on cross-functional and global teams.
• Excellent project management and problem-solving skills.

Benefits

• Health Savings Accounts
• Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• 401k Benefits