Compliance Associate II

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* Responsible for preparing and sending final bioanalytical sample result reports (PK and ADA) in GLP compliant laboratory supporting non-clinical and clinical studies.
* Prepares data tables and bioanalytical summary reports for GLP studies.
* Interacts with CTL management, project management and QA to ensure meeting project timelines
* Acts as liaison with QA and CTL teams to ensure planning, scheduling, review and transfer of data, internal audit responses and study reports
* Communicates, monitors and follows audit responses and required corrective actions and changes with laboratory management and QA.
* Provides support as required to lab management to support lab work flow, personnel and quality systems to ensure continuity of lab operations; may serve as GLP study PI.
* Monitors and ensures relevant study documentation is reviewed and maintained in binders and collaborates with CTL archivist and QA to archive completed study documentation
* Assists with writing, update and review of SOPs, and equipment/software validation documents i.e., user requirements, design, functional spec, IQ/OQ/PQ, and associated reports.
* Identifies and proposes changes/modifications to systems and procedures that improve operational efficiency and compliance of the CTL
* Participates and presents at department meetings.
* Applies knowledge of CFR Part 11 and Part 58 and other GLP regulatory requirements to suggest improvements in operational efficiency and compliance of the CTL