Quality Assurance Supervisor

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Full Time CPMI-Clinical Pharmacology Miami, Miami, FL, US

8 days ago Requisition

Salary Range: $80,000.00 To $95,000.00 Annually

The Quality Assurance Supervisor is responsible for oversight on clinical research operations by way of inspecting and evaluating processes, procedures, and adherence to applicable regulations and guidelines. In addition to supporting Quality Control efforts with data reviews, trend identification and risk management, the QA Supervisor is also responsible for supporting QA related tasks for the site, under the supervision of the Director Quality Assurance and Compliance.

This may include but is not limited to the following:
External/Internal Audits, CAPA, eQMS maintenance, tracking trends and deliverables to completion, and assisting in education and training efforts to reduce quality related problems and increase understanding of our culture of quality. The QA Supervisor is guided by FDA regulations, ICH GCP Guidelines, and company Standard Operating Procedures and policies.

• Working knowledge of FDA regulations, GCP/ICH guidelines, clinic SOP’s and individual protocols
• Perform Quality Control to maintain audit and inspection readiness of studies
• Ensure all study related communication is documented and identify any areas that need further clarification or inconsistencies to the Site Director
• Work with site staff, vendors, and contract employees to obtain quality data
• Review Source Documents, CRF’s, Study Documents, Logs, and Master Files with coordinators and staff to ensure quality, completeness, and accuracy
• Issue queries as applicable for all reviewed documentation and trends queries for systemic issues. Report feedback to Director, Quality Assurance and Compliance
• When directed, review monitor follow-up letters and ensure outstanding issues are resolved
• Meet with sponsors, monitors, and auditors during their visits and document close out minutes as applicable for the Quality Team
• Evaluate audit findings and oversee implementation and effectiveness or appropriate corrective actions under the guidance of Quality Assurance
• Perform QC functions as directed by the Director Quality and Compliance in collaboration with Site Director input
• May assist with developing new Work Practices as they relate to Quality
• Comply with the confidentiality of research data
• Study, learn, and comply with ERG site standard operating procedures and other policies practices and regulations where applicable
• Maintain current training with SOP, WPs, CITI, GCP, and HIPAA
• Process a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and a general understanding of all active study protocols
• Attend meetings, study initiation visits, and all other study-related visits by monitors or sponsor representatives as applicable
• Always represent research site in a professional manner when interacting with sponsors, volunteers, outside vendors, and fellow employees

• Assist with maintaining trackers and/or metrics for all aspects of the Quality Management System components
• Support necessary needs for audit preparation, facilitation, or closure, inclusive of overseeing Sponsor audit report completion activities.
• Support the facilitation and liaising between head of QA and site staff with respect to CAPAs or other risk mitigation efforts.
• Subject Matter Expert (SME) for eQMS system when assigned.
• Provide back-end support for FDA Inspections.
• Site liaison for Quality Assurance/Control and responsible for bringing matters to the attention of the Director QA and/or VP Quality Assurance when appropriate.
• Communicate in a professional and succinct manner both internally as well as with clients when necessary.
• Complete tasks within the projects timelines by prioritizing multiple tasks.
• Demonstrate customer-oriented communication skills responding to Sponsor, management,…