QA Specialist II

Title: QA Specialist II

Location: Abbott Park, Illinois

Duration: 4+ Months

Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• CAPA - Investigates standard testing out of tolerance and out of specification (OOS) results including complaints.
• Supports ticket trending process and maintains quality records.
• Takes ownership and approves any OOS, invalid, and/or aberrant results.
• May write protocols for investigations.
• Communications - Communicate and collaborate effectively within the team and management.
• Documentation - Maintain relevant documents and records.
• Basic Requirements – Performs quality testing in a high-paced laboratory environment.
• Has multiple certifications and is cross trained in other types of assays.
• 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. 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.
• Become an SME on the computer systems.
• Quality/Compliance -Support manufacturing and testing operations as required; adhering to GMPs and GLPs.
• Possess a more involved 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.
• 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 documents and provide adequate feedback.
• Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.
• 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.
• Help with any data pulls or document redlines/updates. Become an SME on lab certifications. Leader within the lab. May also lead lab projects and be called on to attend meetings.
• Advanced computer skills (Word, Excel) are a must.
• 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.