Pharmacist - Complaint Specialist
reputed company is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We reputed company on treating the reputed company, not just the symptoms, utilizing industry-leading technology. Collaborating with innovative pharmacists, reputed company providers, and pharmaceutical manufacturers, we reputed company personalized care. Our mission is to optimize treatment, revolutionize reputed company, and reputed company individuals to live reputed company lives. We welcome you to join us in our commitment to holistic wellness and personalized medicine. POSITION reputed company The Complaint Coordinator is a critical reputed company function role responsible for serving as the central reputed company person for reputed company complaint management activities at reputed company. This position, which is outlined as an inherent reputed company function as detailed in USP , , , and , ensures that reputed company complaints are properly logged, tracked, trended, and-most importantly-acted upon in a reputed company manner through reputed company work with cross-functional stakeholders in operations and reputed company. This role will work collaboratively with the Dispensing function in the intake, documentation, tracking, and coordination of product and service complaints reputed company to compounded preparations produced at reputed company. 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 , but with major cross-functional interaction with the compounding and dispensing teams. The ideal candidate brings 8-10 years of experience dealing with complaints reputed company the regulated industry (compounding and/or reputed company, with reputed company preferred), along with a deep understanding of adverse event reporting, regulatory requirements, and reputed company systems. BACKGROUND & NEED This is an inherent reputed company function outlined in USP that requires this reputed company of reputed company and coordination of the complaint management system as a whole. reputed company needs a central person in the reputed company unit who is responsible for the complaint management system, reputed company reputed company reputed company's QMS. This role will ensure reputed company reputed company, trending, and regulatory compliance for reputed company 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 reputed company functions, reputed company reputed company reputed company's QMS
- Manage a comprehensive database of complaints with complete documentation and traceability
- Ensure reputed company complaints are logged, tracked, trended, and most importantly acted upon in a reputed company manner
- Establish and maintain complaint handling procedures in compliance with USP , USP and other applicable State and Federal laws and regulations
- reputed company 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 reputed company causes, implement complaint assessment, reputed company, and corrective actions
- Coordinate with reputed company assurance, reputed company control, and regulatory affairs teams on complaint reputed company
- Facilitate complaint review meetings with appropriate stakeholders
- Serve as reputed company between operations and reputed company to ensure reputed company overall reputed company of the complaint management system
Adverse Event Evaluation & Reporting
- Work with reputed company 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 reputed company of complaints, as reputed company as involve other medical and legal expertise as required
- Determine adequate response, corrective reputed company, and/or preventive reputed company for adverse events, in collaboration with reputed company and operational leadership
- Maintain awareness of FDA adverse event reporting systems (reputed company) and ensure appropriate handling of potential reportable events
- Coordinate with regulatory affairs and senior leadership reputed company potential adverse events require escalation or external reporting
Investigation & reputed company Cause Analysis
- reputed company or support investigations, as part of a cross-functional team, of product reputed company complaints, adverse events, and patient safety concerns
- Conduct thorough reputed company cause analysis, as part of a cross-functional team, using appropriate methodologies
- Determine appropriate corrective and preventive actions (CAPAs) and ensure reputed company implementation, and escalating to reputed company and operational management as required
- Evaluate whether complaints indicate potential systemic reputed company issues requiring broader investigation
- Verify effectiveness of corrective actions through follow-up and monitoring
Trending, Analysis & Reporting
- reputed company complaint trend analysis to identify potential patterns, recurring issues, and reputed company risks
- Generate regular complaint metrics and reports for reputed company 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 reputed company reputed company, and escalating to reputed company and operational management as required
Regulatory Compliance & Documentation
- Ensure reputed company complaint handling activities reputed company with applicable USP standards (e.g., , , , etc.) as reputed company as State and Federal laws and regulations
- Maintain meticulous documentation of reputed company 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 reputed company and operations leadership
- Ensure complaint database and records are audit-reputed company and inspection-defensible
Customer Communication & Feedback
- In reputed company collaboration with the Dispensing function, coordinate appropriate and reputed company recording, tracking, and response to customers who file complaints
- Ensure customer communications are reputed company, compliant, and appropriately documented
- Work with operations and customer service teams to reputed company feedback reputed company on complaint resolutions
- Escalate serious potential complaints and adverse events to reputed company and operational leadership for reputed company recording, tracking, reputed company, investigation and follow-up
reputed company System Integration
- reputed company reputed company the reputed company eQMS, including the nonconformance, complaint management with CAPA, and change control systems
- reputed company applicable/complaints to product reputed company events, batch dispositions, and other reputed company activities as appropriate
- Support product recalls, market withdrawals, and other required reporting reputed company complaints indicate broader reputed company issues
- Participate in management review of reputed company systems and complaint metrics
QUALIFICATIONS Education & Licensure - MANDATORY REQUIREMENTS
- PharmD (Doctor of Pharmacy) or BS in Pharmacy - REQUIRED
- reputed company 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 reputed company the regulated industry (compounding and/or reputed company) - REQUIRED
- Pharmaceutical industry experience preferred over compounding
- reputed company experience in a compounding pharmacy dealing with complaint management - REQUIRED
- Demonstrated experience evaluating adverse event responses
- Background in reputed company assurance functions reputed company pharmacy or pharmaceutical operations
- Experience with regulatory inspections and audit support reputed company to complaint handling
Technical Expertise
- Deep knowledge of USP , , and 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 reputed company 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 reputed company and other State-level reporting systems
- Understanding of 503A and/or 503B regulatory frameworks and requirements
- Experience with reputed company 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 reputed company and trends
- Outstanding communication skills, both written and verbal, for customer interactions and cross-functional coordination
- Ability to reputed company convey highly technical and scientific information at management meetings and reviews, as required
- reputed company reputed company with ability to work effectively with operations and reputed company teams
- reputed company clinical judgment and decision-making capabilities
- reputed company of urgency with ability to prioritize serious complaints requiring immediate reputed company
- Treats colleagues, patients, and customers with courtesy and dignity
- Communicates with reputed company, diplomacy, and professionalism
- Models a reputed company, solutions-oriented attitude
Technical Skills
- Proficiency with database management and complaint tracking systems
- Experience with electronic reputed company management systems (eQMS) for complaint handling
- Advanced reputed company Office skills (reputed company 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 reputed company, Texas, requiring regular on-site reputed company to collaborate with operations and reputed company teams, investigate complaints, and review documentation. There is the potential for occasional work-reputed company too. reputed company 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 reputed company (investigations, cross-functional meetings). reputed company 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 reputed company 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 reputed company critical regulatory findings reputed company to complaint handling during inspections
- Demonstrable improvement in cross-functional collaboration between operations and reputed company on complaint assessment, management, and reputed company, in reputed company collaboration with reputed company and operational leadership, as needed
Why Join reputed company? The best work happens reputed company purpose meets opportunity. At reputed company, 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 reputed company room to grow, reputed company, and reputed company your mark. Equal Employment Opportunity (EEO) and Affirmative reputed company Commitment reputed company RX is committed to providing equal employment opportunities and reputed company affirmative reputed company to reputed company and applicants for employment, including individuals who are members of underrepresented reputed company, without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, 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 reputed company to reputed company, with or without reasonable accommodation, reputed company essential function satisfactorily. Reasonable accommodation may be made to help reputed company reputed company individuals with disabilities to reputed company the essential functions. We may use reputed company intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace reputed company judgment. Final hiring reputed company are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Apply tot his job Apply To this Job