- This role will be supporting the Quality Control - Bioassay group.
- The candidate will assist the department with testing related activities by strictly adhering to the CLIENT’S policies and procedures and cGMP.
- The candidate filling this position will work to ensure assays are completed in a timely compliant manner, perform cleaning of work areas, equipment, and any other duties as assigned.
1. Assists qualified analysts with current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), the CLIENT’S policies and procedures and safety procedures. This will include assisting the Bioassay department in all aspects of testing with focus on Single Radial Immunodiffusion and ELISA based assays.
2. Performs required testing related activities as per testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand and Stability program.
3. Completes required paperwork and documentation as required.
1. Maintains laboratories in a safe and compliant state.
2. Archiving of raw data associated with testing
3. Performs cleaning of laboratories, equipment, and ancillary areas as required.
1. Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.
2. Document review.
3. Safety and compliance training.
4. Module/Assay training as assigned.
1. Notifies laboratory manager of any deviations or laboratory related issues.
2. Support deviations, change controls and CAPA's.
- B.S. in Biological Sciences, Chemistry or Biochemistry
- 3-5 years experience /Junior level
- Previous experience in a cGMP laboratory is **Highly preferred
- Knowledge of immunological techniques
- **Flu vaccination Required