Job Description
This position is a Technical Writer position which entails creating or revising documents along with documenting, and driving Change Control activities, Corrective Actions, and Deviations.
Own SOPs and Change Controls associated with the process(es) that you are assigned. Assigned process(es) inclusive of clinical and commercial operations of aseptic filling, formulation, equipment preparation, sanitization, visual inspection, analytical testing and/or single use systems.
Own CAPAs and minor Deviations
Participate in internal/external audits.
Preferred Qualifications:
Experience in GMP operations
Technical knowledge of drug product operations
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Desired Skills and Experience WRITE