GMP Deviations Investigation Lead

Kindeva Drug Delivery; Brentwood (MO); On-site; USD 85,000 - 120,000; Full time

Job summary

Kindeva Drug Delivery in Missouri seeks a Deviations Investigation Specialist to partner with Operations, Quality, and cross-functional teams to investigate manufacturing and quality events, determine root cause, and support CAPAs.

You will author investigation records, conduct risk assessments, ensure compliance with GMP and quality systems, and drive improvements across the organization.

Qualifications

• Bachelor degree or equivalent in a related field as listed.
• 3+ years in a GMP-regulated manufacturing environment.
• Experience writing investigations and quality system records.
• Experience with QMS and regulated documentation.
• Experience with root cause analysis and structured problem solving.
• Strong written, analytical, and communication skills.
• Ability to collaborate cross-functionally and influence outcomes.

Responsibilities

• Lead deviation investigations, ensuring timely GMP-compliant completion.
• Collaborate with Operations, Quality, Engineering to gather facts and plan responses.
• Facilitate root cause investigations using structured problem solving.
• Perform risk assessments to evaluate quality and regulatory impacts.
• Author investigation reports with supported conclusions.
• Develop CAPAs addressing root causes and preventing recurrence.
• Maintain deviations, CAPAs, risk assessments, change controls, records.
• Analyze data to identify recurring issues and improvement opportunities.
• Support training to raise investigation quality and compliance.

Skills

Technical writing

Analytical thinking

Communication skills

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering/ Chemistry/ Biology/ Pharmaceutical Sciences/ Quality

Tools

Quality Management System (QMS)

Regulated documentation practices

Root cause analysis methodologies

Job description

Kindeva Drug Delivery in Missouri seeks a Deviations Investigation Specialist to partner with Operations, Quality, and cross-functional teams to investigate manufacturing and quality events, determine root cause, and support CAPAs.

You will author investigation records, conduct risk assessments, ensure compliance with GMP and quality systems, and drive improvements across the organization.