Quality Support Operator 1

Duration: 12 months

Responsibilities 

• Review QMS records, scan, and archive as required to meet regulatory/SOP requirements. 
• Move files or re-locate files, and package boxes supporting QMS records. 
• Interface and manage the record archive process, including P.O’s., with approved suppliers for applicable scanning and storage. 
• Improve and update applicable record archive tools, such as excel 
• Monitor and report action items and task progress and metric updates. 
• Review and audit archive data to ensure accuracy and proper disposition. 
• Support as required Document processing through interactions with document Process Owners and Quality Representatives to meet all Quality Management System requirements for document processing. Utilizes the document management system ) to add, update, control and make obsolete any Quality Management System documents as requested by document Process Owners. 
• Reviews all documents submitted to ensure the use of correct templates and key quality requirements prior to posting the document to the document management system. 
• Maintains records of all documents processed according to QMS requirements 
• Support as needed database administration, quality assurance, change control administration functions and/or training. 
• Quality Assurance review and approval for batch release (Incoming inspection, OEM release, & internal production batch). 

Required Knowledge/Skills, Education, and Experience 


• Ability to primarily work independently. 
• Typically requires 1-2 years successful experience in a document administration role, preferably in a medical device industry or IVD industry. 
• Candidate must be detail oriented, to review documents with specific requirements in mind and ensure the posting process is completed. 
• Ability to prioritize and organize workload to meet business needs and turnaround time requirements. 
• Customer orientation – works in a supporting role and communicates with cross functional teams and partners at all levels in the organization. 
• Follow through - completes the tasks and any needed follow up activities, including escalation of system errors and past due documents. 
• Strong abilities in Microsoft Office applications specifically excel. 
• Experience in SharePoint and SAP preferred 
• Understanding cGMP and GDP 

Preferred Knowledge/Skills, Education, and Experience 

• An associate in related field is preferred. 
• Knowledge of the Quality System Regulations (in particular, overall Quality management system, Document Management and Record retention requirements) 
Key Competencies: 
• Planning and organizing 
• Communications skills 
• Critical thinking and interpretation 
• Adaptability 
• Stress tolerance and workflow flexibility



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