Senior Compliant Investigator, PMC

Job Details: Job Location: Miramar, FL 33025. Position Type: Full Time. Salary Range: $65,000.00 - $70,000.00 per year. Shift: Day. The Senior PMC Investigator is responsible for daily, weekly, and monthly tracking and trending reports of complaints, to support reporting to Aveva Management (Quality Council) as appropriate, and communication to partners/clients, and regulatory agencies. The Senior Investigator is responsible for the timely initiation and for conducting multidisciplinary investigations required in support of complaints, maintaining required cycle times and documenting the investigation results using a validated customer complaints database in compliance with FDA rules, regulations, and expectation. The Senior Investigator supports the compilation of the Annual Product Reviews (APRs) for the commercial products manufactured at Aveva within the required APRs process timelines. Job Responsibilities Manages the complaint handling reporting system, including interacting with management, partners, contractors, and regulatory agencies. Ensures all critical investigations that have potential market impact following the internal escalation procedure. Conducts complaint investigations and ensures multidisciplinary investigations are initiated and completed per requirements. Recognizes critical path for complaint investigations and liaises with appropriate Subject Matter Experts to ensure timely support, identify root cause, and implement corrective & preventive actions. Maintains compliance with procedures and reports, performs weekly, monthly, and other periodic exchanges per regulatory requirements and agreements to ensure compliance with reconciliation requirements for complaints. Analyzes data and reports trends in quality systems and communicates to management team as required. Supports timely submission of Periodic Reports, Annual Reports, and other submissions as assigned for Aveva-owned marketing applications to management. Participates in inspections by regulatory agencies and auditors, and can serve as primary contact or inspection team coordinator. Works as a member of a team to achieve all outcomes. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. All other duties as assigned. Education High school diploma or general education degree (GED). Associate or Bachelor in a scientific/medical discipline preferred. Knowledge, Skills, and Abilities Ability to communicate well in person and in writing with senior management and regulatory authorities. Computer literate in a Windows environment with the ability to use electronic mail system, the Internet and the Microsoft Office Suite including Excel, Word, Power Point, and Access. Competency in writing reports in the English language. Strong organizational skills. Ability to work under minimal supervision and rely on experience and good judgment to plan and accomplish assigned goals. Able to manage multiple tasks simultaneously, be responsive and adaptable to project/task change based on business requirements. Strong interpersonal skills to interface with many levels of an organization. Ability to perform tasks of substantial variety and complexity and to serve as a resource in the resolution of problems and issues. Ability to adapt procedures, techniques, tools, materials, and/or equipment to meet special needs. Coordinating, delegating assignments, training, coaching and reviewing the work of peers. Proficiency in SAP, TrackWise, Word, Excel, Access and ability to learn other software. Physical requirements: allows sitting, reaching with hands and arms, occasional standing and walking, lifting up to 10 pounds. Vision: depth perception and adjustment of focus. Knowledge of transdermal (desired). Experience Minimum of 3-5 years experience in Post Market Compliance or Quality Assurance. Experience managing customer complaint processes, GCPs, GMPs, GLPs, and post‑market safety and surveillance compliance. #J-18808-Ljbffr Aveva Drug Delivery Systems