Complaints Investigation Specialist II
About The Position
The Complaints Investigation Specialist II provides technical leadership and subject matter expertise for the complaints department. The role oversees complaint investigations and supports metric tracking, complaint trending and reviews, potential regulatory reporting assessments, and issuance and tracking of Field Alert Reports (FARs). The specialist serves as the site’s complaint trend analyst, communicating complaint trends to upper management and contributing to post-market surveillance and adverse event reporting. The position ensures complaint handling is timely, professional, and compliant with applicable regulations and internal procedures.
Requirements
- At least 4 years of work experience in pharmaceutical quality, regulatory, or complaint handling roles, or a bachelor’s degree and Quality Assurance experience within the pharmaceutical industry.
- Experience performing product complaint investigations.
- Experience with product trend analysis.
- Experience with technical writing.
- Experience with continuous improvement projects and initiatives.
- Proficiency in Excel and Minitab.
- Working knowledge of cGMP, ICH guidelines, 21 CFR Part 210, 211, and 820, and EU GMP.
Responsibilities
- Serve as the subject matter expert for the Quality Management System (QMS) complaint module.
- Assist with metric tracking, including metrics reported at Tier meetings, monthly reviews, and quarterly reviews such as Quality Management Review.
- Review complaints to determine whether regulatory reporting is required, and issue reports such as FAR assessments in accordance with site procedures, quality agreements, and applicable regulations.
- Review and assist with complaint investigations, providing corrections and feedback to ensure investigations are error-free, comprehensive, and aligned with procedural and regulatory requirements.
- Author complaint trend reports and perform ongoing analysis of potential emerging trends.
- Assess critical complaints for potential new failure modes and lead meetings to communicate complaint trending to upper management.
- Provide complaint data, memos, and other requested documentation for PQRs and other purposes.
- Contribute to activities related to Post-Market Surveillance, Field Alert Reports, and Adverse Event Reporting.
- Lead continuous improvement projects relevant to the department.
- Ensure complaint handling complies with regulatory requirements, including FDA 21 CFR 210, 211, and 820, ISO 13485, GMP, and internal procedures.
- Ensure timely and professional handling of customer concerns.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
