Qa Batch Release Technician Jobs in Indiana

Minimum of 10 years of experience in Quality Assurance and Release Management, with at least 5 years in a leadership role.

Develop and manage the release management process, ensuring that all releases are planned, tracked, and executed efficiently.

Deep understanding of quality assurance practices and a strong background in release management and release cycles.

Strong knowledge of SAP cloud offerings.

All internal transfers must have manager’s approval.

Manage high volume and high risk/complex projects, ensuring that they are delivered on time and within budget.

Controlled issuance of batch records in preparation for manufacturing.

Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.

Assist functional areas with achieving timely and compliant final product disposition of the product.

Ensure Specifications in place and are within GMP compliance.

Organize and file all executed and associated GMP documentation (e.g. batch records).

Maintain batch documentation library (record check-in, check-out, follow-up, and distribution).