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Quality System Specialist

LanceSoft INC
Lexington, Massachusetts, United States
April 27, 2018

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