Manufacturing Operations Specialist
Provide manufacturing support to process and product development projects. Monitor project activities for manufacturing and operations. Collaborate with onsite manufacturing teams and subcontractors/suppliers to ensure product quality, regulatory and business requirements are met. Track progress across projects by reviewing schedules and due dates, identifying risks and implementing contingency plans. Resolve Non-Conformance Reports (NCR), Corrective Action Requests (NCM) and CAPAs by implementing effective solutions. Support validation activities including the execution of protocols for equipment and process validations. Review and contribute to supplier process validation and risk management activities. Assess and approve process changes considering product impact. Compile necessary equipment or capital authorization requests supported with justifications and alternative options. Communicate effectively with internal and external stakeholders. Collaborate with key suppliers and their production/manufacturing teams to drive process/product improvements/developments. Ensure health, safety and environmental requirements are met.