QA Specialist II

Title:QA Specialist II Location:North Chicago, IL 60064 Duration: 06 Months Description: QA Technician is responsible for bioanalytical quality assurance testing within the Starlims and SAP system. Provides inputs to facilitate CAPA investigations as required. Owns and approves any testing events. Maintains product and testing inventory and complies with the quality system. Undertakes the role as Quality Technician and executes daily activities with minimal supervision. Becomes a point of contact for lab issues and may be called on to aid with scheduling activities. Provides input on testing and is an SME (Subject Matter Expert) on their certifications. Core Job Responsibilities: Responsible for implementing and maintaining the effectiveness of the Quality system. Complete Quality testing as appropriate for products per procedures and review all data to determine conformance with specifications. Work in a high-paced laboratory environment and has multiple certifications. Experience with the following is a bioanalytical techniques are a hard requirement: HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry (MS), and microtiter plate methods. CAPA - Investigates standard testing out of tolerance and out of specification results including complaints. Supports ticket trending process and maintains quality records. Communications

• Communicate and collaborate effectively within the team and management. Documentation
• Maintain accurate and complete documents and records. Manage Product and Process Improvements
• Participate in project and process improvement activities. Monitor performance of testing processes, implement process improvements, and foster a culture of continuous improvement. Supports work area processes and product development/improvement projects. Provide quality support to key processes and product development/improvement projects. Takes a lead in the lab to ensure Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) are executed and the lab is running efficiently. Management of Computer Systems
• Maintain and update relevant computer applications. Quality/Compliance
• Support manufacturing and testing operations as required, adhering to GMPs and GLPs. Possess a basic understanding of the Quality System;including the subsystems and is familiar with the Quality System Key processes. Keep abreast of the standards that regulate our industry. Participate and take all training and reviews as required on ISOtrain Learning Management System. Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws;as well at the client Global and Technical standards. Comply with client Quality System (QS) requirements. Share Quality Knowledge
• Shares quality knowledge, liaising with colleagues within team. Training
• Undertakes all training and reviews as required. Sample & File Storage
• Ensures storage of samples and documents in the appropriate filling systems. Lab Safety Participates in lab safety Position Accountability/Scope: Individuals execute daily testing in a high-paced laboratory environment. Perform activities assigned by scheduler/ quality professionals / manager. Identify and escalate any potential non-conformances / issues to quality professionals and manager. Apply appropriate actions to resolve with support from quality professionals. Support relevant activities. Become an SME on lab certifications. Basic computer skills are needed. Minimum Education: Bachelor s in a science or closely related discipline with 3-4 years' experience. Healthcare industry and experience in quality function. Demonstrate excellent communication (written and verbal) skills. Knowledge of manufacturing/testing of diagnostic products, diagnostic methods and applications, excellent troubleshooting skills, product/ process improvement, stability testing, validations, technical troubleshooting, compliance, internal and external audits, and knowledge of performance metrics