Quality Systems Specialist - Sterile Drug Product Manufacturing

Position Overview

We are seeking an experienced Quality Systems Specialist to lead investigations, root-cause analyses, and CAPAs within a sterile drug product manufacturing environment. This role will ensure compliance with FDA, cGMP, ISO, and ICH requirements while maintaining inspection readiness.

Key Responsibilities

• Lead thorough investigations into batch deviations, nonconformances, out-of-specification results, and product failures
• Investigate customer complaints by reviewing production records, historical quality data, and interviewing appropriate personnel
• Perform root-cause and risk analyses and develop appropriate CAPAs
• Ensure investigations and manufacturing documentation comply with FDA, cGMP, ISO, ICH, and other applicable requirements
• Conduct historical quality-system searches to identify similar events, recurring issues, and potential trends
• Prepare and present quality metrics, investigation findings, and reports to support management decision-making
• Partner with Manufacturing and other departments to ensure investigations are accurate, complete, and resolved on time
• Monitor CAPA effectiveness and drive assigned actions through completion
• Lead quality-related training sessions as needed
• Identify and support process improvements related to investigations and quality systems
• Lead the internal audit program
• Assist with hosting client, supplier, and regulatory audits and coordinate responses to audit findings
• Support visual inspection activities for finished products
• Perform other related duties as assigned

Qualifications

• Bachelor’s degree in biology, chemistry, engineering, life sciences, or a related field strongly preferred
• Minimum of four years of experience in pharmaceutical or biotechnology manufacturing
• Significant experience working in a GMP-regulated environment and conducting quality investigations
• Strong knowledge of FDA regulations, cGMP requirements, and ICH guidelines
• Demonstrated experience with root-cause analysis, risk assessment, deviations, CAPAs, and nonconformances
• Excellent technical writing, analytical, and problem-solving skills
• Strong attention to detail with the ability to manage multiple priorities in a deadline-driven environment
• Ability to make sound decisions regarding product and material quality
• Excellent communication skills and the ability to collaborate across departments
• Strong initiative, accountability, and willingness to take ownership of projects through completion
• Experience with MasterControl and NetSuite is a plus