Quality Investigator

Job Title:

Quality Investigator Job Description

The Quality Investigator plays a key role in ensuring manufacturing operations remain compliant, efficient, and aligned with Good Manufacturing Practice (GMP) standards. This position focuses on authoring and managing Quality Assurance Reports (QARs), leading deviation investigations, and driving robust root cause analysis and corrective actions that support timely delivery of critical pharmaceutical products to patients.

• Author, manage, and maintain Quality Assurance Reports (QARs) and deviation investigations related to manufacturing operations and process execution.
• Lead and support investigations into batch record discrepancies, process deviations, procedural issues, manufacturing execution problems, and equipment or material impacts to operations.
• Perform root cause analysis using site‑approved methodologies and ensure conclusions are well‑supported, accurate, and defendable.
• Partner directly with Manufacturing, MSAT, Engineering, Quality Assurance, and Operations leadership to gather detailed and accurate information for investigations.
• Review and interpret batch records, manufacturing documentation, production logs, alarms, process data, SOPs, work instructions, and training records to support investigations.
• Develop clear impact assessments and CAPAs that are aligned with operational risk, regulatory expectations, and site procedures.
• Ensure investigations are completed on time and in full, with thorough documentation that complies with GMP standards and internal procedures.
• Support regulatory inspections, internal audits, and quality metric reviews related to operational deviations and investigation performance.
• Use electronic quality management systems (eQMS), such as Veeva Vault, to document, track, and close deviations and CAPAs.
• Contribute to inspection readiness activities and continuous improvement initiatives within manufacturing and operations quality.

• Bachelor’s degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience.
• Minimum of 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, manufacturing workflows, and GMP documentation practices.
• Hands‑on experience working in electronic quality systems (eQMS), preferably including Veeva Vault.
• Demonstrated expertise in GMP, root cause analysis, CAPA development, and deviation management.
• Excellent technical writing skills with the ability to produce clear, concise, and compliant investigation reports.
• Strong critical thinking and analytical skills to interpret complex manufacturing and process data.
• Effective stakeholder communication skills, with the ability to collaborate across Manufacturing, MSAT, Engineering, QA, and Operations.

• Direct experience supporting aseptic or sterile pharmaceutical manufacturing operations.
• Background in Manufacturing, MSAT, or Operations Quality within a high‑volume pharmaceutical environment.
• Experience supporting regulatory inspections and inspection readiness activities.
• Familiarity with quality metrics and continuous improvement in a GMP setting.
• Motivation to support critical backlog work that helps ensure timely delivery of mission‑critical products to patients and the healthcare system.

This role operates within a pharmaceutical manufacturing environment and office setting. You will work closely with production and quality teams, spending time both on the manufacturing floor and in office areas to review documentation, process data, and…