Business Process Associate at Amneal Pharmaceuticals LLC (J0P) in Glasgow, Kentucky

Job Description:

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.

 

Education

• High School or GED - Required

Work Experience

• 5 years or more in Supply Chain, Inventory or other related fields - Required

Skills and Abilities

• 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

Specialized Knowledge

• Pharmaceutical/ Supply Chain experience preferred


• Knowledge of Serialization and experience being part of the back end mechanics of it in a pharmaceutical / manufacturing industry

 

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.

Apply Now