Senior QC Analyst, Onsite

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Senior Quality Control Analyst or scientist II is responsible for conducting the cell-based potency assays(CBPA) of biologics for release and stability of both commercial and late-stage biologics under current good manufacture practice(cGMP). He/She will prepare all documentation associated with the cGMP testing and independently or in a team setting execute protocols in support of manufacture of AbbVie’s biologics product.

The position is responsible for cGMP compliance of the quality control CBPA laboratory, ensuring that all cell Based Potency Assays testing is performed according to the FDA, foreign MOH and AbbVie requirements.

• Perform cGMP testing in support of the manufacture of Abbvie’s biologics products.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Support new methods validation.
• Perform and execute activities supporting CBPA lab such as equipment validation, equipment preventive maintenance.
• Generate and update SOPs.

AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Re