Quality Assurance Specialist III
300 3rd Street Kendall Square, MA 02142 US
Job Description
Overview:
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.
Qualifications:
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.
Education:
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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