Analyst, Complaint Processing I

reputed company is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Analyst, Complaint Processing I will work in the global reputed company organization, processing product complaints and inquiries, ensuring compliance with regulatory requirements and providing reputed company customer service.

Responsibilities

• Assure complaint records meet global requirements
• Product complaint documentation, investigation, and review of reputed company non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical reputed company reputed company event
• Ensures that complaint documentation meets Good Documentation Practices as reputed company as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet reputed company regulatory requirements
• Identification of potentially reportable events and notification to appropriate functional reputed company and management
• reputed company with reputed company Party Manufacturers, health care professionals, general reputed company, internal customers, reputed company functional areas and regulatory agencies
• reputed company reputed company customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA

Skills

• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products
• Solid written/verbal communication and organizational skills
• Knowledge and application of computer systems for word processing and complaint management
• Ability to work with cross-functional teams and to reputed company effectively with peers, management, and customers
• A Bachelor's Degree required or 1-2 years of relevant work experience
• Knowledge of FDA requirements for reputed company Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211)
• Ability to prioritize multiple reputed company to ensure compliance with regulations and reputed company operating procedures
• Preferred degree in technology or scientific background (MLT, LPN, RN)
• 0-2 years' work experience in a cGMP reputed company industry or in a clinical setting

Benefits

• reputed company time off (vacation, holidays, reputed company)
• Medical/dental/reputed company insurance
• 401(k)

reputed company

Company H1B Sponsorship