Title: QA Specialist II
Location: Abbott Park, Illinois
Duration: 12 Month Assignment
Summary
QA Technician II responsible for bioanalytical quality testing within the QIMS 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 II 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.
Responsibilities
- Responsible for implementing and maintaining the effectiveness of the Quality system.
- Basic Requirements – Performs quality testing in a high-paced laboratory environment and has multiple certifications.
- Experience with the following bioanalytical techniques: HPLC, SDS-PAGE, Western Blot, Dot Blot, Infrared Spectroscopy, UV-Vis Absorbance, ELISA, Mass Spectrometry (MS), 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, implements process improvements, and fosters 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 trainings 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 Abbott Global and Technical standards. Comply with Abbott Quality System (QS) requirements.
- Share Quality Knowledge - Shares quality knowledge, liaising with colleagues within team.
- Training - Undertake all trainings and reviews as required.
- Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.
- Lab Safety – Participates in lab safety
Minimum Education
- Ideally a bachelor’s or master's degree (or equivalent) in a science or closely related discipline and 2-3 years' experience.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.