Senior Quality Assurance specialist at BioMerieux
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Perform all work in compliance with company policy and within the guidelines of its Quality System
Responsible for reviewing, assessing, and monitoring processes and products to ensure compliance with requirements
May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned
Work on quality improvement projects (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
May present project-related information to management as requested
Perform inspection of incoming materials using basic and advanced measurement tools
Perform quarantine activities, including physical and electronic segregation, labeling, physical and electronic release
Initiate NCRs with a thorough description of the nonconformance, including target as well as discrepancy, quantity, and standard used for rejection
Perform and manage sorting activities to completion
Identify the need for WID updates and initiate WID updates
Support and/or manage validation testing, e.g. GR&R and program validation activities
Initiate and author IC documents (Inspection plan)
Support/interact with Materials Management, Engineers, Purchasing, and suppliers
This includes research activities and special projects
Perform sweeps of warehouse area to ensure cGMP compliance with a lead auditor
Review co-worker-completed inspection records
Initiate routines and programs for metrology tools under engineer guidance
Coordinate activities for metrology tool calibration
Ensure compliance to Temporary Change Orders; manage expiration status
Interpret and utilize SPC chart data
Analyze trends and participate in metrics development
Participate as a subject matter expert in internal and external audits of the Incoming Inspection team
Working in a Medical Device Manufacturing company as a senior quality assurance specialist
BSChemistry, Master of public health
