at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
The Quality Assurance Assistant will ensure compliance of manufacturing processes in a GMP environment and will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project-oriented, so the QA Assistant can expect every day to be different with changing responsibilities and priorities.
Key Responsibilities
- Review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance
- Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products
- Conduct facility and/or supplier assessments, raw material release, and line clearances
- Author and update SOPs as needed
- Follow GMP guidelines and adhere to SOPs and GMP requirements
- Communicate QA issues to employees and managers in a tactful manner
- Work on multiple projects at once with changing deadlines and priorities
