Write technical deviations, lead cross functional team, project managements the deviation records and meet timeliness for investigation process.
Responsible for supporting the deviation of major event related large molecule Bulk Drug Substances (BDS) manufactured at Amgen Rhode Island (ARI).
Primary responsibilities of this position include support the investigation process (develops, writes, edits), perform investigation, project manager the owning deviations, CAPA generations, lead functional team, communicate with management when situation is holding the progress of the deviations.
Skills: ; knowledge of process and faculty equipment, and the ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical industry; May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Skills: ; MS Office expertise ; previous technical writing experience ; regulated environment experience ; document version control experience ; excellent communication/writing skills "This posting is for Contingent Worker, not an FTE"