ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Work directly with customers and global regulatory agencies related to regulatory submissions and customer filings
• Complete customer questionnaires related to the facility and systems
• Participate, Host regulatory and customer audits
• Participate during internal audits
• Coordinate audit responses
• Coordinates Regulatory Agency audits with customers and internal staff
• Compiling and presenting metrics in relation to their job performance and performance of the area of responsibility
• Write and implement procedures according to the current regulations
• Generating, reviewing and maintain internal and DEA documentation related to receipts, shipments and inventory
• Submission of information/reports to the DEA (i.e. Quarterly Reports, Annual Reports, Quota Requests)
• Performs other duties as assigned by Supervisor

EDUCATION AND/OR EXPERIENCE:

• High school education or at least five (5) years of pharmaceutical or pharmaceutical packaging experience.

• A college degree with a concentration in a scientific discipline is preferred.

• Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.

• The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Master Control). Ability to create, use and interpret scientific tables, charts, and graphs.