Deviation Writer Job at Harba Solutions Inc. in Indianapolis

We are seeking a detail-oriented Deviation Writer to join our Quality Assurance team. In this role, you will document, investigate, and manage deviations from standard procedures to ensure compliance with internal policies, Good Manufacturing Practices (GMP), and regulatory requirements.

This is a critical position that helps maintain product quality and supports continuous improvement across our operations.

About the Role :

The base pay range for this position is $70,000.00 / yr - $90,000.00 / yr. Your actual pay will be based on your skills and experience.

Key Responsibilities :

• Document and manage deviations, ensuring accurate and timely reporting in the Quality Management System (QMS).
• Conduct investigations to determine root cause and recommend corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams including Manufacturing, QA, and Regulatory Affairs to resolve quality issues.
• Review and ensure deviations comply with internal policies and regulatory requirements.
• Assist in audits and inspections related to deviations and CAPAs.
• Track metrics and trends to support continuous improvement initiatives.

Qualifications :

Equal Employment Opportunity : Harba Solutions Inc. is an equal opportunity employer and welcomes applications from diverse candidates.

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