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Product Complaint Specialist
2 months ago
Job Title: Product Complaint Specialist
Job Summary:
US Tech Solutions is seeking a highly detail-oriented Product Complaint Specialist to join our team. As a Product Complaint Specialist, you will be responsible for processing pharmaceutical, medical device, and combination product complaints and inquiries. You will interface with internal customers, including physicians, nurses, pharmacists, and hospital personnel, to resolve complaints and ensure compliance with regulatory requirements.
Key Responsibilities:
- Process and document product complaints and inquiries in a timely and accurate manner.
- Investigate and resolve complaints, identifying potential adverse events and reportable events as necessary.
- Interface with internal customers, including physicians, nurses, pharmacists, and hospital personnel, to resolve complaints and ensure compliance with regulatory requirements.
- Ensure that complaint documentation meets Good Documentation Practices, GMP, and GCP requirements.
- Identify and report potentially reportable events to appropriate functional groups and management.
- Interface with third-party manufacturers, healthcare professionals, and regulatory agencies as necessary.
Requirements:
- Bachelor's degree in a related field, such as technology or science.
- 0-3 years of experience in a cGMP-related industry or clinical setting.
- 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).
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
- Solid written and 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 interact effectively with peers, management, and customers.
Working Environment:
This role requires sitting at a computer for long periods of time, and the candidate must be comfortable in that type of environment.