Quality Control Specialist

Position Overview

The Quality Control Specialist plays a critical role in ensuring the accuracy, integrity, and compliance of laboratory data, documentation, and quality records. This position performs quality control reviews of study-related data and laboratory documentation, supports quality systems and document control processes, monitors laboratory quality metrics, and contributes to continuous improvement initiatives.

Core Values & Behaviors

• Recognize, exemplify, and adhere to ICON's values centered on People, Clients, and Performance.
• Embrace and contribute to a culture of continuous improvement focused on enhancing efficiency, quality, compliance, and customer satisfaction.
• Demonstrate a strong commitment to quality, accuracy, integrity, and regulatory compliance.
• Collaborate effectively within a team environment and contribute to departmental and organizational goals.
• Communicate professionally and effectively with supervisors, colleagues, Project Leaders, Project Managers, and cross-functional teams.
• Prioritize workload effectively and manage time to meet deadlines.
• Maintain punctual and reliable attendance in accordance with company policy.
• Adhere to all safety procedures and maintain a safe working environment.

Key Responsibilities

• Data Review & Compliance
• Perform quality control (QC) review of study participant results and laboratory run packets to ensure accuracy, completeness, and compliance with applicable SOPs, protocols, and regulatory requirements.
• Conduct review of Biomarker Reports and supporting study documentation to verify data accuracy and integrity.
• Review methods, reports, study data, and supporting documentation for accuracy, consistency, completeness, and proper formatting.
• Identify, document, and communicate data discrepancies, quality issues, and compliance concerns in a timely manner.
• Assist with investigations and resolution of data and documentation discrepancies to support study integrity and quality objectives.
• Provide backup support for Incoming Materials review activities and QC review of Production Batch Records.
• Read, understand, and comply with SOPs, safety requirements, regulatory guidelines, and company policies.
• Documentation & Records Management
• Maintain accurate, complete, and audit-ready records in accordance with regulatory, client, and company requirements.
• Support document control activities, including the creation, review, revision, maintenance, and archival of controlled documentation.
• Develop and support improvements to document control processes to enhance compliance, organization, efficiency, and traceability.
• Compile laboratory notebooks, departmental records, and supporting documentation for archival and regulatory compliance.
• Ensure documentation practices remain consistent, accurate, organized, and inspection-ready.
• Quality Systems & Continuous Improvement
• Compile, maintain, analyze, and report laboratory quality metrics and key performance indicators.
• Develop and maintain tracking tools related to quality events, deviations, errors, and laboratory trends.
• Identify opportunities for process improvement through trend analysis, quality assessments, and operational observations.
• Support continuous improvement initiatives focused on quality systems, documentation practices, compliance, and operational efficiency.
• Respond to Quality Assurance observations and assist with corrective and preventive actions (CAPAs) as required.
• Participate in sponsor audits, regulatory inspections, and quality assessments as needed.
• Cross-Functional Support
• Collaborate with laboratory, operations, project management, and quality teams to ensure timely completion of quality review activities.
• Support departmental projects and initiatives aimed at improving compliance, consistency, and overall laboratory performance.
• Perform additional duties as assigned by management.
• Participate in training and professional development activities to maintain knowledge of industry regulations and best practices.

Qualifications & Experience

• Minimum of five (5) years of laboratory experience in a regulated environment.
• Working knowledge of GxP regulations and applicable industry guidance documents.
• Proficiency with Microsoft Office Suite applications.
• Experience utilizing laboratory instrument data systems.
• Strong attention to detail and commitment to data integrity.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently while collaborating effectively across multiple departments.

Preferred Qualifications

• Experience using JMP statistical software for data analysis, trending, reporting, and visualization of laboratory quality metrics.
• Experience supporting sponsor audits, regulatory inspections, and quality assessments.
• Knowledge of laboratory quality systems, document control processes, data integrity requirements, and Good Documentation Practices (GDP).
• Experience analyzing quality metrics, deviations, investigations, CAPAs, and laboratory performance trends.
• Experience performing quality control reviews of scientific data, validation documentation, reports, and regulated laboratory records.
• Experience working within a pharmaceutical, biotechnology, contract research organization (CRO), or other regulated laboratory environment.
• Demonstrated ability to identify process improvement opportunities and contribute to continuous improvement initiatives.
• Experience collaborating cross-functionally with laboratory operations, Quality Assurance, Project Management, and other technical stakeholders.