Assist with Data Item Descriptions (DIDs), Contract Data Requirements Lists (CDRLs), data calls, and reviews.
November 12, 2022
Understanding and applying effectively auditing standards, firm audit methodology and guidance in work, proactively seeking to apply new guidance and tools in performing audit work.
February 15, 2023
Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
February 18, 2023
Develop and lead with the guidance of their supervisor the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable.
February 26, 2023
Support study-specific regulatory inspection activities at clinical investigator sites by assisting and/or coordinating site inspection preparation activities.
March 09, 2023
Demonstrates thorough knowledge and/or a proven record of success in completing aspects of the Internal Audit process, control evaluation and testing methodologies, and other Financial and Operational Internal Control methodologies and terminology .
April 18, 2023
Plan and execute the day-to-day activities of IT audit engagements for clients, including system development, package implementation, SSAE 16 readiness assessments, and/or platform reviews within multiple industries.
April 21, 2023
Review change request to ensure the proposed changes are clearly described, justified, and validated or verified as completed per the pre-approved change request.
May 04, 2023
Manager of Quality Assurance, GMP in the planning and directing of overall QA activities.
May 14, 2023
Leading teams, emphasizing the supervising of staff by creating a positive working environment through the building of solid relationships with team members, the monitoring of workloads of all team members, adjustment and redistribution of assignments accordingly to promote work/life quality, taking into account team members' capabilities and needs and meeting of client expectations, encouragement of team dialogue, providing candid, meaningful feedback in a timely manner, keeping team members and leadership informed on progress and issues.
May 18, 2023
