Complaint Resolution Specialist
hace 4 semanas
**Job Summary**
We are seeking a highly skilled Complaint Resolution Specialist to join our team at AbbVie. As a key member of our quality assurance team, you will be responsible for ensuring that complaint records meet global requirements.
**Key Responsibilities**
- Assure complaint records meet global requirements.
- Product complaint documentation, investigation, and review of all non-medical complaint content.
- Responsible for reviewing Medical complaints that involve a non-medical quality related problem.
- Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
- Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP.
- Identification of potentially reportable events and notification to appropriate functional groups and management.
- Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.
**Requirements**
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- A Bachelor Degree required or 1-2 years of relevant work experience. (Preferred degree in technology or scientific background)
- 0-2 years' work experience in a cGMP (Good Manufacturing Practice) related industry or in a clinical setting (preferred)
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