Generate and complete all associated documentation using current Good Documentation Practices (GDP) including Batch Production Records;
Maintain accurate records of production, including taking inventory of production and prototype materials through cycle counting and physical inventories;
Set up, operate, and monitor automated and semi-automated equipment used in the assembly process;
Collaborate in the development, setup, and maintenance of cGMP processes at production scale;
Provide feedback and recommendations to the manufacturing engineering team for improvements to manufacturing work instructions, assembly, and test fixtures and processes
Provide feedback and recommendations to supervisors and JH&S Committee regarding Health & Safety concerns/near-misses/incidents;
Apply 5S and lean principles to maintain organization and good housekeeping practices in the manufacturing area;
Work with associated development and engineering teams to incorporate improvements into the manufacturing process based on testing results and observations;
Participate in process FMEAs and risk identification as well as assisting with the implementation of appropriate countermeasures;
Assist Manufacturing Engineering in the setup and validation of new equipment for use in the assembly process;
Execute daily, weekly, and monthly preventive maintenance and cleaning activities of equipment and manufacturing areas;
Support and participate in root cause investigations for, Out-of-Specification (OOS) investigations, Quality Incident Notifications, and CAPA actions related to manufactured products and manufacturing processes;
Maintain a high level of work-related training to ensure consistency of performance, including cross-training on multiple processes within Manufacturing;
