Assistant Manufacturing Coordinator (ASSIS35872) Holly Springs, North Carolina

  • Responsible for coordinating activities to support unit operations.

  • Responsible for review, tracking and closing out executed batch records.

  • Responsible for coordinating system access for manufacturing users and performing transactions in validated material management system (SAP) in support of manufacturing operation

  • Responsible for scheduling manufacturing activities as well as coordinating equipment      maintenance and validation, as needed.

  • Revises standard operating procedures and batch records, implements simple change controls,      and leads simple improvement projects.

  • Provides support with assigned business process systems to support all areas of manufacturing.

  • Identifies and      implements basic continuous improvement projects to improve yield, reliability, and/or process robustness.  This may require leading an implementing change controls.

  • Maintains departmental metrics and key performance indicators (KPIs).

  • Provides training for manufacturing associates.

Strong communication, organizational, and project management skills. Must have a thorough understanding of the pharmaceutical/biotech manufacturing process and equipment, preferably biopharm/vaccines, and current Good Manufacturing Practices (cGMPs).  Must have good analysis, troubleshooting, and investigation skills. Must be able to interact with, and influence others at various levels in multiple departments.

Must be detail oriented, able to excel under pressure as well as demonstrate flexibility, and promptness in dealing with changes, and unanticipated challenges in a matrixed environment. Must have strong computer skills in applications such as SAP, Word, Excel, PowerPoint, Trackwise and other data reporting and analysis tools. Excellent verbal/written communication and presentation skills. Ability to act independently and take initiative. Must be effective at managing time and priorities and display a sense of urgency. Requires multi-tasking / ability to lead multiple projects at one time. Demonstrated ability of influencing others at all levels to drive results.

Minimum of 1 years experience in a regulated environment such as medical devices, pharmaceuticals or biotech/vaccines industry.

Bachelors Degree with 1 year of manufacturing experience or a minimum of 4 years manufacturing experience and equivalent