Job activities include the preparation of equipment and components for aseptic filling operations, performing visual inspection of filled vials, vial labeling, vial packaging and distribution of filled vials as per GMP regulations.
1.Execute daily tasks according to standard operating procedures in support of filling operations such as washing, cleaning and sterilizing equipment and components.
2.Participate in the inspection, labeling and packaging of filled vials.
3.Recording of activities in batch related documentation or equipment logbooks in accordance with good documentation practices.
4.Qualifies as an aseptic operator for the participation of filling activities using isolator technology.
5.Respects and adheres to all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
BS/BA in Biology, Chemistry, or related discipline and 0-2 years experience in a GMP facility or High School Diploma and at least 2 years experience in a GMP facility. Good interpersonal skills and attention to detail. Previous experience working with aseptic technique and good documentation practices preferred, but not required.
IV: Physical/Mental Requirements
Must be able to follow cGMP regulations during operations including adherence to written procedure and contemporaneous documentation. Must be able to record data accurately and legibly, have good manual dexterity, ability to lift 50lbs, demonstrate mechanical aptitude and the ability to perform in a team setting in a controlled environment for long periods of time. Must pass a color blind test. Smallpox vaccination is required.
Sthree US is acting as an Employment Business in relation to this vacancy.