Description
Title: AssociateTechnician Location: Bridgewater, NJ 08807 Onsite role Fulltime positionI. JOB SUMMARY This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance and complaint handling is required. Maintains onsite sample room and mailroom as per departmental SOP.
Responsibilities
Prioritizes complaints for data entry and processing.
Understands the importance of data entry of complaints within the required timeframe.
Understands special details for handling each product within the department.
Understands departmental process flow on drug and device complaints.
Proficient with use of all databases within the department (ie. ACES-Siebel, Global PTC Database, Microsoft Office).
Prepares appropriate correspondence for complaints.
Identifies and prepares appropriate mailers for use in retrieving the complaint samples.
Produces daily reports for follow-up activity.
Reviews and processes reconciliation with Pharmacovigilance.
Process complaint samples upon receipt
Identifies and handles lot discrepancies correctly with returned complaint samples.
Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
Identifies and prepares complaint samples for shipping to manufacturing sites.
Orders departmental supplies.
Identifies complaints for field alert reporting
Performs QC Checks
Provide customer service to consumers, health care professionals, and internal/external departments regarding individual complaints.
Provide support to US Product Quality Complaint Managers/Director during audits by FDA, other regulatory agencies, third parties and internal groups.
Notifies interested departments (including manufacturing sites QA, commercial, regulatory, supply chain) upon receipt of complaints.
Understands the FDA complaints regulations for the drug products and medical devices.
Maintains monthly reports as needed
Provide complaints support to other company departments including but not limited to customer service, medical information, Pharmacovigilance, sales associates, regulatory, commercial operations, legal, and risk management
Maintains sample room and mailroom as per departmental SOP.
