Complaint Coordinator position at ReviveRX Pharmacy, LLC.| United States Of America

ReviveRX Pharmacy, LLC Complaint Coordinator

Experience: 10 Years

Pattern: hybrid

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Bachelor's (B.Sc.)

Houston, TX....United States Of America

ReviveRX is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We focus on treating the source, not just the symptoms, utilizing industry-leading technology. Collaborating with innovative pharmacists, healthcare providers, and pharmaceutical manufacturers, we provide personalized care. Our mission is to optimize treatment, revolutionize healthcare, and empower individuals to live vibrant lives. We welcome you to join us in our commitment to holistic wellness and personalized medicine. POSITION OVERVIEWThe 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, and—most importantly—acted 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. BACKGROUND & NEED This is an inherent quality function outlined in USP <797> that requires this point of oversight and coordination of the complaint management system as a whole. ReviveRX needs a central person in the quality unit who is responsible for the complaint management system, all within ReviveRX's QMS. This role will ensure proper oversight, trending, and regulatory compliance for all complaint handling activities. KEY 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 QUALIFICATIONS Education & Licensure - MANDATORY 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 Experience - CRITICAL REQUIREMENTS •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 Technical Expertise •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 Core Competencies •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 Technical Skills •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 WORKING CONDITIONS This is an onsite role based in Houston, Texas, requiring regular on-site presence to collaborate with operations and quality teams, investigate complaints, and review documentation. There is the potential for occasional work-at-home too. Standard business hours with flexibility required to respond to urgent complaints or adverse events. Occasional evening or weekend availability may be necessary to address time-sensitive patient safety concerns. The role involves both office work (database management, analysis, documentation) and facility presence (investigations, cross-functional meetings). SUCCESS METRICS (FIRST 12 MONTHS) •Establishment of compliant complaint management system per USP, State and Federal requirements •100% of complaints logged, tracked, and documented in centralized database within 24 hours of receipt, per SOP •Achievement of defined complaint response and closure timeframes •Successful adverse event assessment, management, and evaluations with appropriate determinations and responses •Regular trending reports delivered to management with actionable insights •Striving for zero critical regulatory findings related to complaint handling during inspections •Demonstrable improvement in cross-functional collaboration between operations and quality on complaint assessment, management, and resolution, in close collaboration with quality and operational leadership, as needed \n\nWhy Join ReviveRX? The best work happens when purpose meets opportunity. At ReviveRX, you'll work with a passionate, driven team that's redefining what pharmacy can be — with the resources, leadership, and culture to back it up. We offer competitive compensation, strong benefits, and real room to grow, lead, and make your mark.Equal Employment Opportunity (EEO) and Affirmative Action Commitment Revive RX is committed to providing equal employment opportunities and render affirmative action to all employees and applicants for employment, including individuals who are members of underrepresented groups, without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other status protected by applicable federal, state, or local laws. Reasonable Accommodations Statement To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.

Complaint Coordinator job opportunity at ReviveRX Pharmacy, LLC.

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