Sr Associate II, Quality Assurance

JOB PURPOSE: The QA Operations Sr. Associate I assures all operations meet or exceed cGMP regulations, ensuring high level of quality of Bulk Drug Substance. This position is responsible for providing Quality Assurance input and oversight for Downstream process and logistics management as such warehousing and shipping. The position needs reactive support of discrepancy identification, 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.

As such, the position is expected to have expert level knowledge in operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.

MAIN ACCOUNTABILITIES

• Handling shopfloor oversight over the manufacturing operations
• Contribution root cause analysis and corrective action for product and process related non-conformances as SME for minor, major and critical deviation
• Support on product quality impact assessment (PQIA) and process/product risk assessment
• eBR and elogbook review
• Standard Operating Procedures review, revision & approval
• Collect data for metrics and identification of negative trends
• Support as QA SME RA audits, internal audits and supplier audits
• Approximately 6 to 8 years of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment.
• Prior experience with fully electronic operations and management is preferred.
• Good experience of process design a

The QA Operations Sr. Associate I assures all operations meet or exceed cGMP regulations, ensuring high level of quality of Bulk Drug Substance. This position is responsible for providing Quality Assurance input and oversight for Downstream process and logistics management as such warehousing and shipping. The position needs reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances.