Senior Compliant Investigator, PMC

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

4d•$65,000 - $70,000•Onsite

About The Position

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.

Requirements

High school diploma or general education degree (GED), (Associate or Bachelor in scientific/medical discipline preferred)
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.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and reach with hands and arms. The incumbent is frequently required to talk or hear and occasionally required to stand and walk.
The incumbent must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include depth perception and ability to adjust focus.
A minimum of 3-5 years experience in Post Market Compliance or Quality Assurance.
Management of customer complaint processes, GCPs, GMPs, GLPs, and post-market safety and surveillance compliance

Nice To Haves

Knowledge of transdermal (desired)

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; 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 to complaint investigations to identify, root cause, corrective & preventative 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 communicate 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
Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements; All other duties as assigned.