Manufacturing Specialist
: Job Details :

Manufacturing Specialist

Key Responsibilities:

• Support Quality Events for multiple areas of GMP Manufacturing.

• Support and own Quality Events (CAPA, Change Control, deviations, effectiveness checks).

• Work cross functionally with Quality partners to drive all investigations to closure and resolution.

• Perform hands-on data gathering required for investigations.

• Must be able to don gowning materials and enter cleanrooms.

Required Experience & Qualifications:

• BS, MS a plus, in Quality, Life Sciences, or Engineering with minimum of 5-10 years of relevant Quality Events writing / compliance experience. Technical writing skills are highly preferred.

• Experience in MS word, Excel.

• Experience with Veeva highly preferred.

• General understanding of qualification.

• Ability to navigate through OSI PI, BM RAM, DeltaV, SmartSheets, and Kneat is a plus.