Working at Abbott

The Opportunity

This position of Quality Technician works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. The Quality Technician is responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Maintains product and testing inventory and complies with the quality system. Undertakes the role of a Quality Technician with minimal supervision. Redline documents and reviews operating procedures when needed. Execution of daily activities with minimal supervision.

Accountability/Scope:

Individuals execute daily testing in a high-paced laboratory environment. Identify and escalate any potential non-conformances / issues to quality professionals. Work closely with product technical support. Perform activities as assigned by quality professionals / manager. Apply appropriate actions to resolve with support from quality professionals. Support relevant activities. Basic computer skills are needed. Advanced Microsoft Word skills a must.

What You’ll Work On

Responsible for implementing and maintaining the effectiveness of the quality system.

• 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.

• Documentation - Maintain relevant documents and records.

• Basic Requirements – Performs quality testing in a high-paced laboratory environment.

• Manage Product and Process Improvements - Participate in project and process improvement activities. Monitor performance of testing processes and implement required improvement activities. Suggests to manager and implements process improvements within own work area that 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.

• Management of Computer Systems - Maintain and update relevant computer applications.

• Quality/Compliance - Support manufacturing and testing operations as required, adhering to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). 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 the Electronic Training Management System - ETMS. 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 on the Electronic Training Management System - ETMS.

• Testing: Platform lab (Alinity s and/or ARCHITECT) and/or Biochemistry/Chemistry

• Complete quality testing as appropriate per product procedures and review all data to determine conformance with specifications.

• Provide information for tracking and trending of data as required. Take appropriate action per procedural requirements and schedule when test results specifications are not met.

• Redline testing documents and provide adequate feedback.

• Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.

• Lab Safety – Participates in lab safety

Required Qualifications

• Bachelor’s degree (or equivalent) in a science or closely related discipline or relevant equivalent experience