at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
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.