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