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Software Engineer - Software Tester
Location
Virginia
Posted
42 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Software Engineer - Software Tester
Amentum
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• Draft, review or revise Clinical QA SOPs to assess consistency and compliance with regulatory requirements/internal standards. • Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management. • Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary. • Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents. • Assist and advise with training QA and clinical staff as necessary for GCP. • Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. • As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board. • Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management. • Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation). • Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc. • Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs). • Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process. • Assist with inspection readiness, and regulatory inspections as needed. • Other duties and responsibilities as assigned.

