QA Complaint Specialists Position Available In Morris, New Jersey

Position Summary:

We are seeking a detail-oriented and experiencedQA Complaints Specialistto join our Quality Assurance team. This role is responsible for leading investigations into customer complaints, identifying root causes using various methodologies, and implementing effective corrective and preventive actions (CAPAs). The ideal candidate will have a strong understanding of FDA GMP regulations, pharmaceutical manufacturing processes, and a commitment to high-quality standards.

Key Responsibilities:

Conduct and lead investigations into product complaints using root cause analysis tools. Write clear, concise, and timely complaint investigation reports. Evaluate complaints for regulatory reportability and submit reports in compliance with applicable regulations. Collaborate with cross-functional teams to ensure thorough and accurate investigations. Initiate and manage CAPA plans based on investigation findings. Interact with customer service and customers to gather necessary information for complaint resolution. Maintain accurate complaint logs and ensure all documentation complies with SOPs. Review and approve complaint investigations conducted by other team members. Ensure completeness of complaint documentation and proper filing of complaint folders. Initiate and process notifications as required by SOPs. Perform additional duties as assigned.

Qualifications:

Bachelor’s degree in a scientific or technical discipline (preferred). Minimum [X] years of experience in pharmaceutical QA or a related field. In-depth knowledge of FDA GMP regulations and pharmaceutical manufacturing processes. Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Ability to simplify complex technical issues for diverse audiences. Proficiency in using complaint tracking systems and Microsoft Office Suite.