Manufacturing Quality Assistant
Fagron Sterile Services US (FSS), Wichita, KS, United States
Work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. Serve as on the floor presence for line clearances, visual inspection performance, investigation support, deviation/CAPA closure. Every day may be different with changing responsibilities and priorities.
Key Responsibilities
Be able to enter CNC areas to perform all MQ functions as needed.
Support manufacturing through an on the floor presence for line clearances, resolution of issues or elevation.
Perform AQL of visual inspection and labelling operations.
Assist in facility and/or supplier assessments and raw material/component release.
Assist in authoring and updating applicable SOPs as needed.
Follow GMP guidelines and adhere to SOPs and GMP requirements.
Communicate QA issues to employees and managers in a tactful manner.
Assist with multiple project tasks at once with changing deadlines and priorities.
Communicate shift and business needs with leads, pharmacists and colleagues to ensure priorities are met.
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Key Responsibilities
Be able to enter CNC areas to perform all MQ functions as needed.
Support manufacturing through an on the floor presence for line clearances, resolution of issues or elevation.
Perform AQL of visual inspection and labelling operations.
Assist in facility and/or supplier assessments and raw material/component release.
Assist in authoring and updating applicable SOPs as needed.
Follow GMP guidelines and adhere to SOPs and GMP requirements.
Communicate QA issues to employees and managers in a tactful manner.
Assist with multiple project tasks at once with changing deadlines and priorities.
Communicate shift and business needs with leads, pharmacists and colleagues to ensure priorities are met.
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