ProTrials Research Inc.

QA Engineer

• Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/ resolution, including proper and timely documentation
• Facilitates and conducts internal and external audits and provides metrics and analysisof trends based on audit findings
• Assist in the conduct or arrangement of GCP training for all staff
• Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems
• Manage process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs, and trackers
• Responsible for providing quality oversight to the revision, review, and approval of controlled documents
• Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner
• Responsible for providing input and support as appropriate to the creation of new controlled documents
• Works with QA Management and other departments to identify gaps in controlled documents and recommends solutions
• Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training
• Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections, as required
• Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations
• Assist QA management with the evaluation of learning management systems and other QA technology, as required
• Assist in the preparation of quality metrics and reports
• Assist QA management team with other Clinical QA activities as required
• Other duties, as assigned

Quality Assurance Specialist