Real Staffing
Packaging Operations Coordinator
Real Staffing, Novato, California, United States, 94949
Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.Job Description
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 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 to optimize the production schedule.Communicate weekly agenda items and capture discussions in minutes.Act as representative for the monthly inventory close coordination meetings.Other duties as assigned.Qualifications
Skills: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 skills.Education:Bachelors Degree and 1-4 years experience in the pharmaceutical field preferred.Additional Information
All your information will be kept confidential according to EEO guidelines.
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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 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 to optimize the production schedule.Communicate weekly agenda items and capture discussions in minutes.Act as representative for the monthly inventory close coordination meetings.Other duties as assigned.Qualifications
Skills: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 skills.Education:Bachelors Degree and 1-4 years experience in the pharmaceutical field preferred.Additional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr