Biochemist - Deviation Investigations Support

Job Description
Responsibilities include, but are not limited to, the following:
Operate as part of a deviation’smanagement, change control and assay monitoring technical team.
Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented by identifying root cause,identification and implementation of corrective and preventative actions, and authoring the final investigation report
Review data audits and author reports as needed
Ensure investigations adhere to the compliance-driven timeline
Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures.
Qualification and Validation studies
Providing analytical change management support for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs (LOCV)
Technical oversight and execution of Biochemistry quality control assays
Support assay throughout the process including writing protocols, executing assay methods, and writing final reports
General lab duties (includes organizing supplies/media, removal of Biohazardous waste cleaning, stocking, cold room 5S, etc.)