Candidate will work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as on the floor presence for line clearances, aseptic audits, visual inspection performance, investigation support, deviation/CAPA closure. The MQA Assistant can expect every day to be different with changing responsibilities and priorities.
- Be clean room qualified and ability to maintain qualification on a routine basis.
- Support manufacturing through an on the floor presence for line clearances, resolution of issues or elevation. Perform aseptic audits of the manufacturing process.
- Perform AQL of visual inspection and labelling operations.
- Assist in facility and/or supplier assessments and raw material/component release.
- 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
- 2+ years Pharma experience with Quality experience preferred.
- HS Diploma, Bachelor’s degree preferred.
- Experience working in a laboratory or process manufacturing setting
- Experience working in a regulated environment (GMP)
- Ability to be clean room qualified and maintain qualification routinely
- Have 20/20 vision, correctable with glasses/contacts
- Be able to be visual inspection qualified and maintain qualification
- Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressure
- Strong verbal and written communication skills
- Technical writing and review ability
- Desire to work in an office setting as this position is not laboratory focused
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.