Provide support to the Operational Quality Systems Group to ensure the CAPA, Change Control and Deviation processes deliver results efficiently and effectively. Collaborate with the business process owners (BPOs) to assist process users and customers with guidance on the processes and to ensure successful execution of the processes through tracking, trending and general oversight for compliance.
Describe the essential daily job functions and include % of time spent on each.
% of Time Job Function and Description
20% Maintain status reports for systems and drive compliance to agreed upon dates
20% Support the BPOs in providing technical, procedural, and compliance based guidance to system users as needed
20% Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs).
15% Support training for Quality Systems processes as needed
15% Support the BPOs in follow-up with record owners and tracking and trending of record status
10% Other duties as assigned by management
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and
necessary licenses or certificates. Specify which are required and which are preferred. For UK,
please do not use years of experience due to UK Legislation
• College degree preferred
• Experience with Quality Systems required
• Change Control, CAPA and Deviation experience related to GMP / GDP / Medical Device preferred
• TrackWise experience a plus
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