Laboratory Technical Support Specialist

Job Description

Lab Tech Support Specialist responsibilities include, but are not limited to, the following:

Operate as part of a deviation's management, 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

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.

Support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility.

Support laboratory investigations including identification of root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report

Qualification and Validation studies

Providing analytical change management support for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs (LOCV)

Coordination of all analytical change activates in the LOCV laboratories

Support key commitments for analytical change within Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility

Technical oversight of Biochem quality control assays

Execution of various Biochem assay testing

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.)