JobMesh

Document Reviewer II - QA- Afternoon Shift

Thermo Fisher Scientific · CA

Work Schedule Second Shift (Afternoons) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (saf...

Job description

Work Schedule Second Shift (Afternoons) Environmental Conditions: Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Summary: Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory . Verif y and confirm the integrity and traceability of all data generated and reported. This position is M-F 3:00pm-11:30m. Essential Functions: Review all regular technical documents (e.g., batch testing, stability testing , method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time . Release Raw Material and Packaging Components in SAP Release of P roduct C ertificate of A nalysis using applicable LIMS software Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists /chemists. Verif y the integrity and traceability of all data generated and reported. Follow up with scientist/chemists to ensure that all necessary corrections are corrected in...