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Quality Auditor
Ref No.: 19-05125
Location: Tucson, Arizona
 See Attached Job Description for Full Description
 
At the Molecular Solutions level, consults and/or leads the Roche business area/ unit internal audit process and/or business methods. May work with executives and management to incorporate and implement process improvements. Oversees system improvements,and selection and implementation of technological advances within the scope of the quality system. Establishes and acts upon trend analysis and other metrics to improve business unit/ area quality systems and/or regulatory compliance. Performs quality system and business process audits as assigned. Analyzes existing processes and implements process improvements using quality standards. Ensures that products meet design specifications and are within quality management limits and standards via the internal audit process.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
Responsibilities  
Performs business quality system audits – includes audit preparation, conducting audits, writing audit reports, communicating findings to suppliers, business, and stakeholders, and audit follow-up.  
Continuously improves the effectiveness of existing quality systems and processes by converting quality system related deficiencies identified through audit findings into improved system and process practices.  
Reviews and approves corrective action plans and actions as a result of audit findings.  
Effectively executes and/or follows-up on CAPA (Corrective and Preventive Action) Quality System non-conformance or improvements. Performs all activities in full compliance with Roche Molecular Solutions quality policies and procedures.
  • Makes decisions with some level of oversight.
 
Verifies closure of corrective actions and preventive actions from audits.  
Determines statistical sampling of documents and records to be reviewed during audits.  
Prepares audit trend reports.  
Supports sites, affiliates, departments, and areas across Roche Molecular Solutions to sustain compliance against applicable standards and regulations.