Quality Associate Operations Upstream

The QA Operations Sr. Associate I assures that all operations meet or exceed cGMP regulations ensuring the quality of Cell Banks and Bulk Drug Substance supporting on shop floor the daily upstream manufacturing and facility operations.

The position needs reactive support of discrepancy identification on cell culture and fermentation processes, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances. The holder will collaborate with product Quality Management for change control. This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures. This position will support quality key metrics and analysis.

This role is expected to be cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.

*LI-POT4

The position is expected to have expert level knowledge in cell culture, fermentation, operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise,

We are looking for QA Sr. Associates I for the Quality Operations Upstream Department. This position is responsible for providing Quality Assurance input and oversight.