Quality Investigator

Job Title:

Quality Investigator Job Description

The Quality Investigator plays a key role in ensuring compliant, reliable pharmaceutical manufacturing by leading investigations into deviations, authoring high-quality Quality Assurance Reports, and driving effective corrective and preventive actions. This position supports operations by analyzing process and documentation issues, partnering closely with cross-functional teams, and helping the site deliver critical products to patients on time while meeting regulatory and GMP standards.

• Author, manage, and maintain high-quality Quality Assurance Reports (QARs) for deviations related to manufacturing operations and process execution.
• Lead and support investigations into batch record discrepancies, process deviations, procedural issues, and manufacturing execution problems.
• Investigate equipment or material impacts on operations and assess their potential effect on product quality and compliance.
• Conduct root cause analysis using site-approved methodologies and ensure conclusions are clear, well-supported, and defendable.
• Partner directly with Manufacturing, MSAT, Engineering, Quality Assurance, and Operations leadership to gather accurate and complete investigation details.
• Review and interpret batch records, manufacturing documentation, production logs, alarms, and process data to identify trends and root causes.
• Evaluate and interpret SOPs, work instructions, and training records to determine procedural gaps or compliance issues.
• Develop robust impact assessments that clearly define product, process, and compliance risks associated with deviations.
• Design and propose effective Corrective and Preventive Actions (CAPAs) aligned with operational risk, regulatory expectations, and site standards.
• Ensure all investigations are completed on time, thoroughly documented, and fully compliant with site procedures and GMP requirements.
• Support regulatory inspections, internal audits, and quality metric reviews related to operational deviations and quality events.
• Utilize electronic quality systems (eQMS), such as Veeva Vault, to document investigations, manage workflows, and track CAPA implementation.
• Apply strong technical writing and critical thinking skills to produce clear, concise, and logically structured investigation reports.
• Contribute to inspection readiness activities by ensuring deviation and CAPA records are complete, accurate, and easily retrievable.
• Support backlog reduction efforts to help the site release products to patients on time and maintain a reliable supply to the healthcare system.

• Bachelor’s degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience.
• At least 2 years of experience supporting operations-based deviations and quality investigations in a GMP manufacturing environment.
• Proven ability to independently write, manage, and close investigations tied to manufacturing processes.
• Strong understanding of batch record review and manufacturing workflows in a regulated environment.
• Solid knowledge of GMP documentation practices and compliance expectations.
• Hands-on experience working in electronic quality management systems (eQMS), including platforms such as Veeva Vault.
• Demonstrated proficiency in root cause analysis methodologies within a GMP setting.
• Experience developing and managing Corrective and Preventive Actions (CAPA) to address deviations and systemic issues.
• Strong technical writing skills with the ability to create clear, accurate, and well-structured investigation reports.
• Excellent critical thinking and problem-solving skills applied to complex manufacturing and quality issues.
• Effective stakeholder communication skills, with the ability to collaborate with cross-functional teams in Manufacturing, MSAT, Engineering, QA, and Operations.
• Direct experience supporting aseptic or sterile manufacturing operations.

• Prior experience at a high-volume pharmaceutical manufacturing site.
• Experience supporting regulatory inspections and inspection readiness activities.
• Background in Manufacturing, MSAT, or Operations Quality.
• Experience…