Product Complaint Analyst
3 days ago
We are seeking a highly skilled Product Complaint Analyst to join our global quality organization. The ideal candidate will have experience in product quality complaints, particularly in medical device complaint handling, and will play a key role in processing pharmaceutical, medical device, and combination product complaints.
Key Responsibilities:
- Process product complaints and inquiries, including documentation, investigation, and coordination of follow-up activities.
- Collaborate with internal and external stakeholders, including physicians, nurses, pharmacists, healthcare professionals, manufacturing sites, and third-party manufacturers, to resolve complaints.
- Identify potential adverse events and reportable events, and notify relevant functional groups and management as required.
- Ensure complaint records meet global regulatory requirements (GMP, GCP, and Good Documentation Practices).
- Assist with the creation and submission of regulatory reports and customer communications.
- Manage return samples for investigation and coordinate replacement of products when needed.
- Use complaint management systems and maintain thorough and accurate records in compliance with FDA and global regulations (21 CFR 803, 820, 211).
- Provide audit support as necessary and maintain compliance with internal processes and external regulatory guidelines.
Required Skills and Qualifications:
- Bachelor's degree required; preferred fields: Technology, Life Sciences, Nursing (e.g., MLT, LPN, RN).
- 1-3 years of experience in a cGMP-related industry or clinical setting.
- Proficiency in MS Excel (pivot tables, sorting, filtering) is essential.
- Detail-oriented with excellent organizational and communication skills (both verbal and written).
- Ability to work independently in a cubicle environment and take initiative to improve processes.
- Adaptable to changing business needs and self-motivated with a focus on efficiency.
- Knowledge of FDA regulations and global quality requirements for pharmaceutical and medical devices, including 21 CFR Part 803, 820, 211, is preferred.
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
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