Deviations Investigation Lead — GMP Quality & CAPA

Kindeva Drug Delivery; Maryland Heights (MO); On-site; USD 85,000 - 115,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Deviations Investigation Specialist to join our Production Operations – Compliance Investigation group. You will lead deviation investigations, assess root causes, and develop CAPAs in collaboration with Quality, Engineering, and Operations.

You will author clear investigation records, perform risk assessments, and ensure compliance with GMP and quality systems while driving continuous improvement across manufacturing processes.

Qualifications

• Bachelor's degree in a related discipline or equivalent combination of education and experience.
• 3+ years in a GMP-regulated manufacturing environment.
• Experience with quality management systems and regulated documentation practices.
• Experience with root cause analysis and structured problem-solving methodologies.
• Strong technical writing, analytical, and communication skills.

Responsibilities

• Lead deviation investigations related to manufacturing and operational events, ensuring timely completion and compliance with site quality systems and GMP requirements.
• Partner with Operations, Quality, Engineering, Validation, and other stakeholders to gather facts, assess impact, establish containment actions, and determine appropriate response plans.
• Facilitate root cause investigations using structured problem‑solving methodologies and data‑driven analysis to identify the most probable causes of events.
• Perform and document risk assessments to evaluate product quality, regulatory, operational, and business impacts.
• Author clear, thorough, and technically sound investigation reports, ensuring conclusions are supported by facts, evidence, and data.
• Develop and support corrective and preventive actions (CAPAs) that address root causes and reduce recurrence.
• Author or support quality system documentation including deviations, CAPAs, risk assessments, change controls, effectiveness checks, and related records as required.
• Analyze investigation data and trends to identify recurring issues and opportunities for continuous improvement.
• Support training, coaching, and collaboration efforts to improve investigation quality, problem‑solving capabilities, and compliance across the organization.

Skills

Root cause analysis

Technical writing

Analytical thinking

Communication skills

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Quality, Business, or related discipline

Job description

Kindeva Drug Delivery is seeking a Deviations Investigation Specialist to join our Production Operations – Compliance Investigation group. You will lead deviation investigations, assess root causes, and develop CAPAs in collaboration with Quality, Engineering, and Operations.

You will author clear investigation records, perform risk assessments, and ensure compliance with GMP and quality systems while driving continuous improvement across manufacturing processes.