Deviations Investigation Lead – GMP & CAPA

Kindeva Drug Delivery; Missouri; On-site; USD 80,000 - 110,000; Full time

Job summary

Kindeva Drug Delivery seeks an Deviations Investigation Specialist to partner with Operations, Quality, and cross-functional teams to investigate manufacturing events, determine root cause, assess risk, and support CAPAs. The role leads deviations investigations and ensures accurate, compliant records in GMP systems.

The candidate will identify systemic issues and drive sustainable improvements in product quality and manufacturing performance.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• 3+ years in a GMP-regulated manufacturing environment.
• Experience authoring, investigating, reviewing, or approving deviations and investigations.
• 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.
• Ability to collaborate cross-functionally and influence outcomes.

Responsibilities

• Lead deviation investigations related to manufacturing and operational events, ensuring timely completion and GMP compliance.
• Collaborate with Operations, Quality, Engineering, Validation and others to gather facts and determine containment actions.
• Facilitate root cause investigations using structured problem-solving and data-driven analysis.
• Perform and document risk assessments evaluating product quality and regulatory impact.
• Author investigation reports with conclusions supported by facts and data.
• Develop and support CAPAs addressing root causes and reducing recurrence.
• Support documentation for deviations, CAPAs, risk assessments, change controls, and effectiveness checks.
• Analyze investigation data and trends for recurring issues and improvement opportunities.
• Assist training and coaching to improve investigation quality and compliance.

Skills

Deviation investigations

Root cause analysis

Quality systems

Technical writing

Cross-functional collaboration

Regulatory inspections

CAPA

GMP

Education

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

Job description

Kindeva Drug Delivery seeks an Deviations Investigation Specialist to partner with Operations, Quality, and cross-functional teams to investigate manufacturing events, determine root cause, assess risk, and support CAPAs. The role leads deviations investigations and ensures accurate, compliant records in GMP systems.

The candidate will identify systemic issues and drive sustainable improvements in product quality and manufacturing performance.