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Quality Assurance Specialist III

Kendall Square, MA 02142

Posted: 04/22/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 605340 Is job remote?: No Country: United States

Job Description


The Quality Assurance Specialist III of Clinical and Commercial FG Quality Operations is responsible for providing support to GMP aspects of Clinical and commercial finished goods assembly, packaging, and labeling with a primary focus on Clinical. This role will work cooperatively with their counterparts throughout Quality Operations to provide quality oversight and support to ensure clinical and commercial lifecycle activities meet GMP regulatory requirements and guidelines. This position reports to the Senior Manager - FG Quality Operations.

Key Responsibilities:

Execute quality oversight of manufacturing clinical and US commercial finished goods assembly/packaging/labeling up through lot disposition to include review and approval of Deviations, Change Controls, CAPAs.

Provide quality oversight of our external clinical and US commercial finished goods manufacturing network quality management systems, ensuring compliance with regulations in all relevant markets.

Perform data migration activities in support Product Specification File expansion.

Three (3) to five (5) years of relevant QA work experience in a regulated industry
Experience of first hand GMP management is preferred, and will include exposure to FDA or other authorities of similar standing.
Operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times.

Minimum BS degree in life sciences, engineering or related field.

Pay ranges on $28-35/hr and is based on expereince 
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About Kendall Square, MA

Ready to take your career to the next level? Explore job opportunities in the vibrant tech hub of Kendall Square, Massachusetts! With its close proximity to prestigious universities like MIT and Harvard, Kendall Square offers unparalleled growth opportunities and a dynamic work environment. Enjoy the bustling atmosphere, cutting-edge innovation, and diverse array of restaurants featuring local favorites like lobster rolls and clam chowder. Catch a show at the American Repertory Theater or take a stroll along the Charles River Esplanade for stunning views. Join the local excitement of cheering for the Boston Red Sox at Fenway Park or immerse yourself in the rich history of the region at the Museum of Science. Discover your dream job in Kendall Square and embrace the endless possibilities that this thriving area has to offer!

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