Senior Product Complaint Specialist

Key Responsibilities

• Lead, conduct and document Product Quality Complaint investigations from initiation through closure.
• Perform root cause analysis using structured investigation tools and methodologies.
• Assess product impact and support risk evaluations.
• Develop, implement, and track CAPAs to completion.
• Collaborate with Manufacturing, Suppliers, Quality Control, Engineering, Supply Chain, and other functions to gather information and drive investigation outcomes.
• Ensure investigations are completed in accordance with GMP requirements, company procedures, and established timelines.
• Identify and recommend continuous improvement opportunities within the Quality Management System.

Qualifications & Experience

• Bachelor's degree in scientific discipline such as Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related field.
• Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment.
• Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations.
• Strong understanding of cGMPs, quality systems, and regulatory expectations.
• Proficiency in root cause analysis and risk assessment methodologies.
• Excellent written communication, analytical, and problem-solving skills.
• Ability to manage multiple investigations and work effectively in a cross-functional environment.