QA Data Reviewer

4 weeks ago


Worcester Massachusetts, United States AbbVie Full time
Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The QA Data Reviewer supports the Quality Function that they are responsible for within Operations. This could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the QA Data Reviewer will maintain high quality levels in all aspects of their job while achieving high levels of efficiency.

Responsibilities

Performs batch record review independently, with a strong focus on attention to detail and “right first time” in order to achieve batch record cycle/release times.

Support daily production activities conducting on the floor batch review and ensure completion of corrections in a timely manner.

As required, oversee changeover operations in manufacturing.

Responsible for various aspects of quality assurance and quality control related to their functional area.

Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.

Support troubleshooting and resolution of quality compliance issues.

Communicates with Management for Quality Management Review, Quality Initiatives, etc.

Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.



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