Packaging Material Development Associate
On-site · Augusta, Georgia, United States
Job Summary
Packaging Material Development Associate supports PMD activities including supplier qualification, prospecting new suppliers, and organizing/testing packaging materials. Responsible for development and maintenance of artworks and specifications, overseeing creation/review/approval/release of artwork and codes, and open change management related to artwork/specifications. Manages PMD-related project implementations, participates in CM meetings, and assists with process improvements and documentation such as SOPs, drawings, specifications, and analytical methods. Provides syringe component support, participates in safety activities, interacts with regulatory agencies during audits, performs root cause analysis for deviations, and supports CAPA implementation. Requires a BS in a related field, 2+ years in FDA-regulated manufacturing, strong cGMP knowledge, and excellent communication and project-management skills.
Required Qualifications
- Education: A BS degree in Chemistry, Engineering or related field.
- Experience: 2+ years experience in FDA regulated manufacturing operations.
- Understanding and experience with pharmaceutical cGMPs, preferably related to prefilled sterile syringe manufacturing and packaging requirements.
- Strong written and oral communication skills.
- Excellent organizational, project, and time management skills.
- Strong interpersonal and communications skills to work in a team-based environment and interact with regulatory agencies.
- Strong technical knowledge and problem solving skills.
- Ability to manage multiple priorities independently.
- Strong computer skills (Excel, JMP, Visio, etc.).
- Ability to travel to all areas of the plant;Occasional travel <20%.
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