QA Specialist II - Intellectt INC

Role: QA Specialist II

Location: Abbott Park, IL - 60064-3500

Duration: 7 Months

Shift Timings: 8 AM to 4:30 PM

Job Description:

Core Job 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.

Manage Product and Process Improvements - Participate in project and process improvement activities. Monitor performance of testing processes and implement required improvement activities.

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

Share Quality Knowledge - Shares quality knowledge; liaising with colleagues within the team.

Training - Undertake all training 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.

Minimum Education:

Ideally a bachelor's or master's degree (or equivalent) in a science or closely related discipline and 2-3 years' experience.

Interview preferences : onsite