Quality Lab Associate - QCIS

Simtra BioPharma Solutions•Bloomington, IN

9d•Onsite

About The Position

The Microbiology Quality Lab Associate I performs complex routine and non-routine sampling and processes samples in support of the Microbiology department. This position reports to a Microbiology Supervisor. 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.

Requirements

Bachelor’s degree required in a science related field, preferably Microbiology.
Previous experience working in a GMP regulated environment preferred.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples JDE, BPLM, Pilgrim, Trackwise, etc.)

Responsibilities

Performs testing (bioburden, sterility, growth promotion, etc.) on finished products and in process samples.
Performs investigational work in support of out of specification samples, using training and scientific method to identify root cause and corrective actions.
Documents and processes samples in a Laboratory environment.
Investigates and authors Microbiology investigations.
Enter test data into Laboratory Information Management System (LIMS)
Participate in continuous improvement activities.