<p>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.</p> <p>Job Description</p> <p>The Senior Quality Control Analyst 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 set execute protocols in support of manufacture of AbbVie's biologics product.</p> <p>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.</p> <ul> <li>Perform bioassay testing in support of the manufacture of Abbvie's biologics products. </li><li>Review and approve raw data and laboratory logbooks/worksheets. </li><li>Perform cell culture and cell banking in support of routine testing. </li><li>Manage critical reagents and supplies. </li><li>Write quality systems records including laboratory investigations, change controls, non-conformances. </li><li>Support regulatory inspections where needed. </li><li>Participate in CBPA method transfers and validations. </li><li>Support laboratory equipment preventive maintenance and the qualification of new laboratory equipment. </li><li>Authoring and review of documents such as protocols, reports, test methods, SOPs. </li></ul> <p>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 Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.</p> <p>Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.</p> <p>Qualifications</p> <ul> <li>MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience. </li><li>Experience with the application of aseptic cell culture, cell banking and 96-well format bioassay techniques for potency determination of proteins and their degradation and modification products. </li><li>Skills in the use of and programming multiple equipment for bioassays, such as Synergy2, Neo2, MSD imager, Luminex Plate reader. Experience in the application of liquid handlers in cell-based assay automation and related software for data analysis is a plus. </li><li>Skills in addition to bioassays including West blot, qPCR, qELISA and antibody conjugation (HRP and biotin) are preferred. </li><li>Ability for technical troubleshooting, in particular, root cause analysis and CAPA development/implementation is a must. </li><li>Proficiency in TrackWise quality system, Microsoft Project, and Excel. </li><li>Experience in working in cGMP regulated environment is required. </li><li>Well developed written and oral communication skills. Motivate to work in a team environment. </li><li>Consistently deliver on commitments and respond to department needs in a timely and courteous manner. </li></ul> <p>Additional Information</p> <p>Applicable only to applicants</p>