MedFocus Quality Specialist III 7786 in Texas
Job description: Summary: Under direct supervision, provides support to the department supervisor as a team leader and subject matter expert in a variety of complex duties associated with managing product complaints and supporting patients/customers associated with Company pharmaceutical, biologics, and combination products. The Quality Specialist III will initiate, own, processes, maintain, and conclude complaint files including determination of the appropriate investigation team based on manufacturing/packaging site and complaint type and nature. Results of the investigation will be incorporated into the complaint record and the Quality Specialist III will determine the appropriate root cause, conclusion, and action plan based on the investigative findings. This includes facilitation of product replacement and reimbursement as needed. Additionally, the Quality Specialist III will assist in monitoring intake and processing workloads and timelines.
Key Duties and Responsibilities: 1. Initiate, evaluate, assess and maintain complaint files, following complaint handling internal procedures. Analyze information obtained and create children records to be assigned to the site of manufacture/packager. Critically think how the reported event is best processed and investigated based on the global Company structure.
Initiate and set up child records. Maintain and update Global TrackWise database. Record all complaint activity in both hard copy (when applicable) and TrackWise records.
Assess incoming documentation from intake group and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Adverse event and off label usage complaints are to be reported to Pharmacovigilance. Combination events, such as Lack of Effectiveness, will be shared with both Product Quality and Pharmacovigilance.
Expedite shipments for Complaint Sample Retrieval. Maintain oversight on location of complaint sample to provide status to sites as requested.
Solicit investigation status updates directly from site of manufacture/packager and evaluate analysis results on all submitted records.
Collaborate with manufacturing sites, packaging sites, third party quality, and corporate quality to make and document appropriate regulatory decisions.
Advise site to initiate further complaint investigations, and provide any additional follow-up and communication pertinent to the product complaint as needed.
Track and control files sent to site of manufacture/packager for investigation and complete necessary documentation and monitor timelines.
Evaluate Complaint Investigation results, and close records when all requirements are met.
Maintain a knowledge and understanding of current product labeling, other federal laws governing pharmaceutical complaints, Department of Transportation (DOT) requirements for complaint sample returns, and other global regulatory requirements as needed.
Process, evaluate and maintained files for reconciliation reports with various departments.
Act as a Subject Matter Expert in department responsibilities and act as a team leader as needed. This includes:
Team oversight and guidance.
Monitoring of daily activities and team performance.
Monitoring of workload distribution, processing timelines, procedural/regulatory compliance, and overall record quality.
Support of global complaint processing as needed.
Collaboration with global Company colleagues.
Backup and delegate for the department supervisor.
Develop, implement, and lead company, departmental and product knowledge as required:
Communicate and provide critical feedback and direction to a variety of departments such as Quality Assurance, Customer Relations, Operations, Marketing, Medical Information, Global Safety and Epidemiology departments, and Company/Third Party manufacturing/Packaging facilities, Physicians, Pharmacies, etc.
Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing “talking points” and communicating corporate policy.
Support and monitor department product reimbursement.
Ensure team is applying product reimbursement based on procedural and business guidelines
Inform internal and external customers of Company’s reimbursement policy and product return requirements.
Ability to monitor several cases at once, including status and follow-up as necessary.
Respond to verbal and written requests from internal and external customers for compensation of product quality complaints and adverse events.
Ability to identify potentially litigious customers, and forward to management for resolution.
Identify, initiate, and lead projects within the department. Projects may include:
Lead special projects as directed by department leadership
Write/revise department procedures as assigned.
Train new staff and conduct training/re-training on company policies, and departmental practices.
Assist in performing complaint audits.
Provide project and team leadership as needed.
- Participate in Regulatory Inspections and potentially directly interact with auditors during regulatory inspections.
Minimum Requirements: Education and Experience Bachelor’s degree, with three to five years of previous experience in Quality, Regulatory, Clinical, and/or Customer Management (in a regulated environment) setting; or equivalent combination of education and experience. Previous leadership experience. Essential Skills and Abilities
Ability to act as a Subject Matter Expert in complaint management and customer interactions.
Ability to act as team leader associated with various department activities.
Ability to problem solve through vague and unclear information.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents.
Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
Ability to use word processing, spreadsheet, and database applications. Ability to learn various and multiple software programs.
Ability to handle confidential data in accordance with HIPAA and related international standards.
Ability to function in a controlled environment regulated by the FDA and other regulatory authorities. This encompasses knowledge of current regulatory requirements, guidelines, and interpretations. It also includes potential regulatory inspections participation. The specific requirements include, but may not be limit
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