Complaint Coordinator

ReviveRX and Ways2Well•Houston, TX

1d•Onsite

About The Position

The Complaint Coordinator is a critical quality function role responsible for serving as the central point person for all complaint management activities at ReviveRX. This position, which is outlined as an inherent quality function as detailed in USP <797>, <795>, <800>, and <1163>, ensures that all complaints are properly logged, tracked, trended, andâmost importantlyâacted upon in a timely manner through collaborative work with cross-functional stakeholders in operations and quality. This role will work collaboratively with the Dispensing function in the intake, documentation, tracking, and coordination of product and service complaints related to compounded preparations produced at ReviveRX. Due to the medical nature of most complaints and the need to evaluate potential adverse events, this role requires a licensed pharmacist with extensive compounding pharmacy experience, and <795>, but with major cross-functional interaction with the compounding and dispensing teams. The ideal candidate brings 8-10 years of experience dealing with complaints within the regulated industry (compounding and/or pharma, with pharma preferred), along with a deep understanding of adverse event reporting, regulatory requirements, and quality systems.

Requirements

PharmD (Doctor of Pharmacy) or BS in Pharmacy - REQUIRED
Active pharmacist license in good standing (Texas license preferred or ability to obtain) - REQUIRED
Due to the medical nature of most complaints, this role MUST be filled by a licensed pharmacist
8-10 years of experience dealing with complaints within the regulated industry (compounding and/or pharma) - REQUIRED
Pharmaceutical industry experience preferred over compounding
Direct experience in a compounding pharmacy dealing with complaint management - REQUIRED
Demonstrated experience evaluating adverse event responses
Background in quality assurance functions within pharmacy or pharmaceutical operations
Experience with regulatory inspections and audit support related to complaint handling
Deep knowledge of USP <797>, <795>, and <800> requirements for complaint handling in compounding operations
Comprehensive understanding of State and Federal laws and regulations, and adverse event reporting needs/requirements
Clinical expertise to assess medical significance and patient safety implications of complaints (will be done through cross-functional collaboration with other functional teams)
Knowledge of pharmacology, drug interactions, and adverse drug reactions
Familiarity with MedWatch and other State-level reporting systems
Understanding of 503A and/or 503B regulatory frameworks and requirements
Experience with root cause analysis methodologies and CAPA systems
Exceptional organizational skills with ability to manage a thorough complaint management system systematically
Strong attention to detail with meticulous documentation practices
Excellent analytical and critical thinking skills to assess complaint significance and trends
Outstanding communication skills, both written and verbal, for customer interactions and cross-functional coordination
Ability to clearly convey highly technical and scientific information at management meetings and reviews, as required
Collaborative mindset with ability to work effectively with operations and quality teams
Sound clinical judgment and decision-making capabilities
Sense of urgency with ability to prioritize serious complaints requiring immediate action
Treats colleagues, patients, and customers with courtesy and dignity
Communicates with tact, diplomacy, and professionalism
Models a positive, solutions-oriented attitude
Proficiency with database management and complaint tracking systems
Experience with electronic quality management systems (eQMS) for complaint handling
Advanced Microsoft Office skills (Excel for trending/analysis, Word for documentation)
Ability to create metrics, dashboards, and data visualizations
Familiarity with pharmacy management systems and patient records

Responsibilities

Complaint Management System Ownership
Serve as the central person responsible for tracking, trending, and ensuring complaints are assessed, acted upon, and acted upon by responsible people in the operations and quality functions, all within ReviveRX's QMS
Manage a comprehensive database of complaints with complete documentation and traceability
Ensure all complaints are logged, tracked, trended, and most importantly acted upon in a timely manner
Establish and maintain complaint handling procedures in compliance with USP <797>, USP <795> and other applicable State and Federal laws and regulations
Develop and implement key performance indicators (KPIs) for complaint management and response times
Cross-Functional Collaboration & Coordination
Collaboratively work with cross-functional stakeholders to ensure complaints are properly managed
Partner with teams in the compounding, dispensing, and operations areas to investigate complaint root causes, implement complaint assessment, action, and corrective actions
Coordinate with quality assurance, quality control, and regulatory affairs teams on complaint resolution
Facilitate complaint review meetings with appropriate stakeholders
Serve as liaison between operations and quality to ensure proper overall quality of the complaint management system
Adverse Event Evaluation & Reporting
Work with Quality and Operations leadership to determine if complaints are deemed adverse events relating to Federal and State reporting requirements
Apply clinical and pharmacological expertise to assess medical significance of complaints, as well as involve other medical and legal expertise as required
Determine adequate response, corrective action, and/or preventive action for adverse events, in collaboration with quality and operational leadership
Maintain awareness of FDA adverse event reporting systems (MedWatch) and ensure appropriate handling of potential reportable events
Coordinate with regulatory affairs and senior leadership when potential adverse events require escalation or external reporting
Investigation & Root Cause Analysis
Lead or support investigations, as part of a cross-functional team, of product quality complaints, adverse events, and patient safety concerns
Conduct thorough root cause analysis, as part of a cross-functional team, using appropriate methodologies
Determine appropriate corrective and preventive actions (CAPAs) and ensure timely implementation, and escalating to quality and operational management as required
Evaluate whether complaints indicate potential systemic quality issues requiring broader investigation
Verify effectiveness of corrective actions through follow-up and monitoring
Trending, Analysis & Reporting
Perform complaint trend analysis to identify potential patterns, recurring issues, and quality risks
Generate regular complaint metrics and reports for quality management and senior leadership
Identify opportunities for process improvements based on complaint data
Present complaint trends and insights at management review meetings
Monitor complaint closure rates and aging to ensure timely resolution, and escalating to quality and operational management as required
Regulatory Compliance & Documentation
Ensure all complaint handling activities comply with applicable USP standards (e.g., <797>, <795>, <800>, etc.) as well as State and Federal laws and regulations
Maintain meticulous documentation of all complaints, investigations, and resolutions
Present completed complaint files and documentation for regulatory inspections and audits, as required
Respond to regulatory inquiries regarding specific complaints or complaint handling systems, in collaboration with quality and operations leadership
Ensure complaint database and records are audit-ready and inspection-defensible
Customer Communication & Feedback
In close collaboration with the Dispensing function, coordinate appropriate and timely recording, tracking, and response to customers who file complaints
Ensure customer communications are professional, compliant, and appropriately documented
Work with operations and customer service teams to provide feedback loop on complaint resolutions
Escalate serious potential complaints and adverse events to quality and operational leadership for timely recording, tracking, action, investigation and follow-up
Quality System Integration
Further integrate the current eQMS, including the nonconformance, complaint management with CAPA, and change control systems
Link applicable/complaints to product quality events, batch dispositions, and other quality activities as appropriate
Support product recalls, market withdrawals, and other required reporting when complaints indicate broader quality issues
Participate in management review of quality systems and complaint metrics