Analyst, Complaint Processing I
AbbVie
1 month ago
Remote friendly (North Chicago, IL)
United States
Operations
Purpose:
- Process pharmaceutical, medical device, and combination product complaints and inquiries within the global quality organization.
- Interface with internal and external customers (e.g., physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales, general public, manufacturing sites, technical support, commercial organization, and PV) regarding product complaints.
- Responsible for product complaint documentation, investigations, and identification of potential adverse events and potentially reportable events.
Responsibilities:
- Assure complaint records meet global requirements.
- Perform complaint documentation, investigation, and review of all non-medical complaint content; review medical complaints involving a non-medical quality-related event.
- Ensure complaint documentation meets Good Documentation Practices as well as GMP and GCP; ensure complaint files meet regulatory requirements.
- Identify potentially reportable events and notify appropriate functional groups and management.
- Interface with third-party manufacturers, healthcare professionals, general public, internal customers, AbbVie functional areas, and regulatory agencies.
- Provide quality customer service by coordinating return samples for investigation and follow-up actions (replacement of product, complaint categorization, and CAPA).
Qualifications:
- 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, 211) (preferred).
- Ability to prioritize multiple projects to ensure compliance with regulations and SOPs (preferred).
- 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 interact effectively with peers, management, and customers.
- Bachelor’s degree required or 1–2 years relevant work experience; preferred technology or scientific background (MLT, LPN, RN).
- 0–2 years work experience in a cGMP-related industry or in a clinical setting (preferred).
- Process pharmaceutical, medical device, and combination product complaints and inquiries within the global quality organization.
- Interface with internal and external customers (e.g., physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales, general public, manufacturing sites, technical support, commercial organization, and PV) regarding product complaints.
- Responsible for product complaint documentation, investigations, and identification of potential adverse events and potentially reportable events.
Responsibilities:
- Assure complaint records meet global requirements.
- Perform complaint documentation, investigation, and review of all non-medical complaint content; review medical complaints involving a non-medical quality-related event.
- Ensure complaint documentation meets Good Documentation Practices as well as GMP and GCP; ensure complaint files meet regulatory requirements.
- Identify potentially reportable events and notify appropriate functional groups and management.
- Interface with third-party manufacturers, healthcare professionals, general public, internal customers, AbbVie functional areas, and regulatory agencies.
- Provide quality customer service by coordinating return samples for investigation and follow-up actions (replacement of product, complaint categorization, and CAPA).
Qualifications:
- 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, 211) (preferred).
- Ability to prioritize multiple projects to ensure compliance with regulations and SOPs (preferred).
- 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 interact effectively with peers, management, and customers.
- Bachelor’s degree required or 1–2 years relevant work experience; preferred technology or scientific background (MLT, LPN, RN).
- 0–2 years work experience in a cGMP-related industry or in a clinical setting (preferred).