Job Description
This is an intermediate position. Candidate will be required to self study/training on the FDA guidelines associated with Drug Supply Chain Security Act (DSCSA). Under limited direction, the Business Process Associate assists with implementing, executing, and overseeing the business analysis, coordinating with manufacturing (Internal and Contract Manufacturers) and downstream trading partners 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
- Troubleshoot and resolve transaction errors within set KPIs for distribution centers and customers
- 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.
- Document and analyze the Information needs of the business and ensure appropriate solutions are delivered
- Partner with business clients and delivery teams to determine appropriate solutions
- Oversee and modify changes to Special Operating Procedures (SOP) as it pertains to DSCSA
- 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
Education
QUALIFICATIONS
- Associate Degree - Preferred
Experience
- 3 years or more in Supply Chain, Inventory or other related fields
- 3 years or more in Previous Computer and Microsoft office experience
- 3 years or more in Customer Service
Skills
- Excellent communication skills both written and verbal - Advanced
- Ability to multitask - Advanced
- Ability to retrieve information from all levels within a company - Advanced
- Be a self starter and be motivated to provide a solid product quality and customer service - Intermediate
- Ability to see big picture and be a critical thinker - Intermediate
- Strong ability to self manage including time lines, conference calls etc - Intermediate
- Problem Solving - Advanced
Specialized Knowledge
- Pharmaceutical/ Supply Chain experience preferred
- Knowledge of DSCSA and Serialization
- Experience being part of the back end mechanics of it in a pharmaceutical / manufacturing industry
- Microsoft Excel
About Us
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
