Packaging Operations Coordinator

Duties:

The Packaging Operations Coordinator is responsible for supporting the Packaging Operations team to ensure that all clinical and commercial production needs are defined and met and the financial transactions are properly accounted. Coordinate all clinical and commercial material needs between the various manufacturing groups and the project teams to ensure that all clinical and commercial product needs are defined and met. Point person for the setup and management of all Oracle transactions

Responsibilities:

• Initiate and manage label changes following regulatory guidance’s and clinical operations needs

• Facilitate translations for clinical label development

• Create and receive purchase orders for all production based on approved quotes

• Manage the routing and printing of Clinical labels

• Manage internal and external inventory

• Complete tasks within the Oracle ERP system as related to production. Including Item Setup, Label Production and Batch Record completion.

• Reconcile and maintain inventory internally and at the CMO locations working with the Finance and Quality groups.

• Initiate Change Control through the Trackwise system.

• Support Packaging Specialists as needed as needed to optimize the production schedule.

• Communicate weekly agenda items and capture discussions in minutes.

• Proficient in MS Office

• Proficient with Oracle or other materials management systems knowledge desired.

• Act as representative for the monthly inventory close coordination meetings.

• Other duties as assigned.

Qualifications

Skills:

• Oracle or ERP experience desired

• Working knowledge of clinical supply aspects of IND/NDA requirements, and current GMP/GCP regulations desired.

• Working knowledge of manufacturing processes

• Proficient in MS Office: Word, Excel, Outlook, PowerPoint, and MS Project

• Excellent organizational, interpersonal communication, and problem-solving skills

• Ability to find, communicate, and implement ways to continuously improve processes

• Proficiency with Oracle or other materials management systems knowledge desired

• Process development or technology transfer experience preferred.

• Excellent written and verbal communication skills.

• Strong quality orientation with attention to detail

• Networking and negotiation skill

Education:

Bachelors Degree 1-4 years experience in the pharmaceutical field preferred

Additional Information

All your information will be kept confidential according to EEO guidelines. 

IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 619-452-2903 ASAP! I want to know more about your preferences.

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