Job Summary
This is an entry level position. Candidate will be required to self study/training on the FDA guidelines associated with Drug Supply Chain Security Act (DSCSA). The Business Process Associate follows daily routine and duties assigned by Business Process Supervisor. Assists with implementing, executing, and overseeing the business analysis, coordinating with manufacturing (Internal and Contract Manufactures) to ensure activities such as case labeling, EPCIS event data and Serialized GTIN(s) engage with Amneal Distribution Software and other functionalities, assist with daily logistics and distribution applications/processes to transition Amneal to meet the FDA DSCSA and it's assigned milestones. This position reports to the Business Process Supervisor and will work with various departments to develop, implement, and maintain measures to ensure Amneal is compliant with the DSCSA. The main responsibility for this position is to align Amneal's serialization process to the DSCSA regulations as well as future manufacturing rules and regulations.
Essential Functions
+ Maintain business processes impacted by serialization operations.
+ Assist and or oversee with the implementation of new serialization requirements in step with the DSCSA timeline.
+ Support User Acceptance Testing by working with the business and help define test scope, scenarios to be tested, identify areas of impact requiring regression testing, etc.
+ Troubleshoot and resolve transaction errors within set KPIs for distribution centers and customers.
+ Oversee and modify changes to Special Operating Procedures (SOP) as it pertains to DSCSA
+ Partner with business clients and delivery teams to determine appropriate solutions
+ Document and analyze the Information needs of the business and ensure appropriate solutions are delivered
+ Manage the project implementation activities and ensure that the solution delivered meets the business requirements
+ Work cross-functionally to insure interdependencies and milestones are properly integrated into the project plans
Additional Responsibilities
+ Partner with business clients and delivery teams to determine appropriate solutions Conduct risk assessment against the user requirements
+ Assist in the development of detailed work practices/user documentation and training
+ Manage the project implementation activities and ensure that the solution delivered meets the business requirements Coordinate with project management counterparts to plan project schedules, timeliness and deliverables to insure alignment of US and International deliverables.
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