Complaints Investigation Specialist II

Kindeva Drug Delivery•Los Angeles, CA

3d•$72,000 - $92,000•Onsite

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, complaint reviews for potential regulatory reporting, and the issuance and tracking of Field Alert Report (FAR) assessments. The specialist ensures compliant, timely, and professional handling of customer concerns and contributes to post-market surveillance, adverse event reporting, and continuous improvement activities.

Requirements

Minimum of 4 years of work experience in pharmaceutical quality, regulatory, or complaint handling roles, or a bachelor's degree; a science-based field is preferred.
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 Parts 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, including FAR assessments, as required by 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.
Serve as the site complaint trend analyst by authoring complaint trend reports, analyzing potential emerging trends, assessing critical complaints for potential new failure modes, and leading meetings to communicate complaint trends to upper management.
Provide complaint data, memos, and other requested documentation for PQRs and related needs.
Contribute to Post-Market Surveillance, Field Alert Reports, and Adverse Event Reporting activities.
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.