Production documentation clerk

The Manufacturing Clerk plays a crucial role in the final review of DHRs, verifying compliance with quality standards, GDPs, and applicable regulations. The role requires close collaboration with production, engineering, and quality teams to resolve discrepancies and drive continuous process improvement.

• Inspect and review the production DHRs according to specifications, Visual Aids, and method sheets. 
• Responsible for ensuring the supply of all manufacturing documentation to the area, such as DHRs, forms, labels, logbooks, and work orders as required. 
• Must be able to identify, handle, and manage priorities according to the different process requirements. 
• Establish and maintain control of all GDP errors, categorized by type and responsible person. Follow up on the first pass yield for the area. 
• Ensure that all associated documentation, such as production records, quality controls, and tests, is complete and compliant with standards. 
• Print necessary documentation for manufacturing, as required to ensure the continuity of operations (Batch records, work orders, logbooks, labels). 
• Properly handle the scrap labels and forms resulting from the process that must be submitted to the Release department for the corresponding material release. 
• Actively participate in and identify document opportunities (Improve DHR documents). 
• Notify the designated supervisor when a non-conformity is found. 
• Perform other tasks or assignments as required by management or the assigned supervisor. 
• Ensure compliance with regulations for logbooks in the production areas. 
• Manage and complete the unit confirmation process in the operations system (Report as Finished), ensuring the proper use of production tools (D365, Smartsheets, Power BI, etc.). 
• Perform other tasks or assignments as required by management or the assigned supervisor. 

Knowledge, Skills, and Abilities:

• Proficiency in using systems and software packages such as Microsoft Office, Smartsheet, and Dynamics 365. 
• Ability to review and comprehend written instructions, including blueprints, specifications, and method sheets. 
• Attention to detail. 
• Knowledge of GDPs and GMPs. 

 

Work Environment:

• Occasionally lift 25 kg or more.
• Spend extended periods in front of a computer.

 

Experience:

• 1+ years of experience in medical devices industry 
• 1 year of experience in the Media Value Stream. 

 

Education:

• 9th grade of Secondary Education. High school diploma (desirable).