Our client is seeking a QA Lab Specialist to support inspections, audits, and quality improvement initiatives across multiple laboratory environments. This role will assist with evaluating laboratory testing processes, identifying trends, supporting CAPA activities, and ensuring continued compliance with domestic and international regulatory standards such as USP and ISO 17025.

Responsibilities

• Conduct routine inspections of laboratory processes and facilities to ensure adherence to quality standards.
• Review and assess testing procedures, inspection methods, and documentation for opportunities to improve efficiency and compliance.
• Analyze test reports and laboratory data to identify trends and areas for corrective action.
• Assist with both internal and external audits, contributing to preparation and execution of audit plans and follow-ups.
• Support the Risk Analysis and CAPA processes, including documentation and follow-up of quality events.
• Maintain up-to-date knowledge of quality standards and regulatory requirements (e.g., USP, ISO 17025).
• Ensure compliance with applicable domestic and international regulations governing laboratory testing and quality systems.
• Collaborate with cross-functional teams to drive process improvements and quality assurance initiatives.

Qualifications

• Bachelor’s degree in Science, Engineering, or a related technical field.
• Minimum of 2 years of experience in a Quality role, preferably in a laboratory, medical device, or pharmaceutical setting.
• Working knowledge of quality systems, laboratory inspections, and process improvement.
• Strong analytical skills with experience in statistical quality control and trend analysis.
• Familiarity with risk management, deviation handling, and CAPA processes.
• Excellent problem-solving and time management skills, with the ability to manage multiple projects and priorities.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Location

• Mundelein, IL

Employment Type

• W2 employee, contract and/or contract to hire

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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