Laboratory Technician III

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Job description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter, Facebook, Instagram, YouTube and LinkedIn. Responsible for supporting QC Laboratory team in activities associated with the daily operations of the QC Microbiology Laboratory, performing laboratory testing and analysis. Coordinates, and evaluates the activities of associates in the Microbiology Lab, including laboratory testing for in-process and finished good products, environmental monitoring, validation studies. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO and USP guidelines. Experience with E beam Sterilization, Endotoxin test, Sterility test, AATB guidelines is desirable. Must be able to lift 25 lbs and Comfortable with Clean room gowning requirements. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Essential Duties and Responsibilities: 20 % Assure timely support to QC Lab, Production, R&D, Tissue Services, Validation, Regulatory Affairs, Supplier Quality, Change Control, CAPA, OPEX, Engineering, Manufacturing Services, and other groups as required. People: 15 % Actively participate in the training and certification of new employees and existing employees. Under the limited supervision of a senior technician or other supervisory title, the QC Lab Technician III will participate in both outreach and laboratory work. Department Support: 45 % Perform Viable & Non-viable Environmental Monitoring, Facility Water test Sterility test using isolator technology, Sterility test validation, Biological Indicator studies, Bacterial Endotoxin Test (BET), and BET validations, Microbial identifications, Disinfectant qualification studies, Growth Promotion Test of media/diluents, preparation of cryopreserved microbial cultures, and media/diluent preparation. Support microbiology team for Quarterly dose audit for terminal sterilization using E-Beam technology. Provide support in Out of Specification (OOS) investigations, Non-Conformance (NC) investigations, and Corrective Action / Preventative Actions (CAPA). Perform microbiological tests to support the continuous workflow within QC Department. Under the direction of the QC Laboratory Manager (as applicable), assists in all the periodic inspection of laboratory facilities to assure that they are operated and administered according to Good Manufacturing Practices and Good Laboratory Practices. Actively assist QC Management with the FDA and other regulatory/audits. Execute validation studies, prepare summary reports, and change controls. Stay current on laboratory instruments and methods. Ensure completion of all protocols, validations, and summary reports in a timely manner. Ensure adequate supplies and equipment are available for testing. Communications and Data Management: 20 % Ensure testing is performed as per determined schedules and in line with regulatory requirements. Ensure effective recording, analysis and reporting of Micro KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement. Attend Departmental and TIER meetings. Hold the agreed number of Team Meetings. Attend other meetings as directed by the QC Laboratory Manager. Provide review of local and corporate documents. Auditing and maintenance of all laboratory procedures. Prepares trending reports for quality control testing, environmental monitoring, and other laboratory testing as required. Qualifications Education and Experience High school diploma or equivalent. Minimum 3 to 5 years of experience in performing duties as listed in duties/responsibilities in GMP environment in aseptic processing facility. Experience with standard laboratory equipment (as defined in below section) Experience with routine laboratory testing and/or environmental monitoring. Essential Skills: Demonstrated knowledge of sterilization process and aseptic processing cleanroom regulations, industry practices, and related AATB, AAMI, ISO, and USP standards and FDA regulations. Perform protocol driven studies for Bacteriostasis/Fungistasis, bioburden, endotoxin, sterility testing, Environmental Monitoring, Disinfectants, etc. Experience with Microsoft Office, including Word, Excel, PowerPoint, and Outlook. Excellent organizational and project management skills and ability to handle multiple projects. Thorough understanding of scientific strategies and ability to support QC Management to implement new methods or new techniques to support continuous improvement. Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings. Have knowledge of how to operate laboratory equipment such as autoclave, pH meter, SAS Super 180, Climent non-viable air particle counter. Able to be gown certified. Significant Work Activities Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.