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Job Summary
The Manufacturing Associate will support the daily operations of the pharmaceutical manufacturing process, ensuring that production schedules are met while maintaining the highest quality standards. This role involves participating in production activities (inventory management, preparation, filling, inspection, labeling, packaging), supporting the implementation of efficient processes, and supporting QMS and batch related documentation.
Essential Job Duties And Responsibilities
- Assist in day-to-day manufacturing operations, including media fills and production activities.
- Wear containment garb for long periods in ISO areas (may include mask, suit, safety glasses, boots/shoe covers) and perform garb certification training.
- Ensure production schedules are met while maintaining high standards of quality and efficiency. First shift schedules may be extended depending on need.
- Support the procurement and staging of manufacturing materials to ensure inventory is maintained to support day-to-day operations without interruption.
- Support the implementation of new processes and the improvement of existing ones to enhance productivity and efficiency.
- Follow all safety protocols and procedures and complete batch documentation with good documentation practice.
- Partner with Quality Assurance and Quality Control to support quality management system outputs (such as investigations, root cause analysis, out of specification results, CAPA, and complaints).
Education And Essential Qualifications
- High school diploma or equivalent. Some advanced training preferred.
- Dependable, can multitask with good communication skills, and can work well in a team environment
- Experience with sterile injectables and pharmaceutical manufacturing.
- Strong attention to detail and ability to follow procedures accurately.
- Basic understanding of quality management systems (QMS) and regulatory requirements in pharmaceuticals.
Desirable Qualifications
- Previous experience working with any of the following preferred: contract manufacturing organizations (CDMO/CMOs), international teams, start-ups and routine business, combination products, sterile injectables.
- Experience with electronic quality management systems and ERP within highly regulated industry.
- Able to thrive in a fast-paced, changing environment and manage multiple priorities.
ADA Requirements
- Typically sits, grasps items and performs keyboarding for frequent operation of a computer
- Stand, walk, bend, reach or otherwise move about regularly
- Lift, move, or otherwise transfer items up to 40 lbs. occasionally, >20 lbs. frequently
- Occasional exposure to typical machine shop physical hazards
LS1439271- MS_1764188752