Key Responsibilities:
Perform testing for in-process, lot release, stability studies, investigations, transfers, and validations.
Review assays and support technical transfer activities.
Write and maintain Quality Records, including Deviations, CAPA, Change Control, and test methods.
Participate in projects such as method transfers, new instruments, and method qualifications.
Use laboratory computer systems and Microsoft Office (Word, Excel, PowerPoint).
Utilize GMP Quality Systems such as TrackWise and LIMS.
Work with laboratory software including SoftmaxPro, Empower, and SoloVPE.
Support software validation activities, including writing GMP ...