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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.
Job Responsibility:
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
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)
Requirements:
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
Nice to have:
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
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