Job Description

Role: QA Specialist

Location: North Chicago, IL 60064

Duration: 12 Months

Shift: AM to 5 PM

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First priority : Local to Illinois

Top 3 5 Skills Needed for each role

• Quality Systems
• Good Communication Skills
• Project Management
• Familiar with Aseptic Process
• Combination Product

Hybrid, remote M, F, onsite T, W, R

Travel Required: Y/N Y, ~20%

• The QA Senior Specialist is responsible for providing quality assurance support for the pharmaceutical plant.
• This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Develop plans, coordinates and drives for execution Quality projects across multiple site QA areas.
• Coordinate with site QA planners to achieve project deliverables.
• Coordinate with centralized function the deployment of global Pharma 3 initiatives.
• Analyze, manage and maintain data for cycle times, touch times, and tasks/process lists to optimize QA processes performance.
• Drive for development, improvement and maintenance of site QA planning and scheduling activities.
• Assure QA areas under scope of the project implement and maintain visual management tools to monitor key QA processes.
• Analyze and report metrics for planned and unplanned activities for key QA processes.
• Anticipates and identifies areas of risk and mitigates risks through early risk assessments and implementation of fallback / mitigation strategies.
• Lead development of the Project Charter and documents the requirements that satisfy the stakeholders' needs and expectations.
• Establish project objectives and criteria for evaluating project results and activities of the project team.
• Support Regulatory inspections for new market introduction.
• Lead and or coordinate Compliance and Performance improvement projects. Provide status to site management of the assigned projects.
• Maintains an effective liaison and cooperative relationship with Quality areas from Third Party Contractors (TPC)

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