Quality Analyst - Batch Review

The role

The Quality Analyst I is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Review. They perform review of all quality documentation generated during filling operations and effectively communicate with customer support departments.

Responsibilities

• Perform batch record review for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Facilitate an environment of partnership and communication between Quality Assurance, Production and other support functions to ensure timely Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
• Initiates nonconformance investigation reports.
• Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
• Perform final batch record review, product release / disposition of GMP batches produced at Simtra
• May require client interaction

Qualifications

• Bachelors degree required
• Experience in pharmaceutical quality or pharmaceutical manufacturing preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)