Quality Analyst - Batch Review

Simtra BioPharma Solutions•Bloomington, IN

5d•Onsite

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. 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.

Requirements

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.)

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