Specialist Deviation Investigations

KBI Biopharma • Boulder, CO

4d

About The Position

Conducts investigations into manufacturing deviations, documenting findings, determining root causes, and recommending corrective and preventive actions (CAPAs). Supports quality system programs. Supports cGMP manufacturing operations for manufactured biopharmaceutical products.

Requirements

• cGMP manufacturing operations for manufactured biopharmaceutical products.
• Data gathering, interviews, and analysis of deviations.
• Documentation of investigation findings, root causes, and CAPAs.
• Application of investigation techniques and problem-solving skills to identify root causes.
• Identification and escalation of complex issues.
• Support for the implementation and effectiveness checks of CAPAs.
• Working knowledge of GMP and regulatory requirements.
• Support for quality systems programs (deviations, CAPA, continuous improvement).
• Effective collaboration with cross-functional teams.
• Ability to work on a range of deviations with varying complexity.

Responsibilities

• Conducts investigations, including data gathering, interviews, and analysis of deviations.
• Documents investigation findings, root causes, and CAPAs.
• Applies investigation techniques and problem-solving skills to identify root causes.
• Identifies and escalates complex issues.
• Supports the implementation and effectiveness checks of CAPAs.
• Maintains a working knowledge of GMP and regulatory requirements.
• Supports quality systems programs (deviations, CAPA, continuous improvement).
• Collaborates effectively with cross-functional teams.
• Works on a range of deviations with varying complexity.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed