Quality Control Analyst

Company Description About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube. Job Description Purpose: Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Responsibilities: Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods. Performs, coordinates and supports method validations and prepares final reports documenting the validation findings. Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing. Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action. Reviews and approves all laboratory testing documentation. Responsible for the preparation of Test Failure Investigation reports. Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in SAP and LIMS. Responsible for leading others indirectly. Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager. Must make sure that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOP’s are available to all laboratory personnel Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues. Qualifications Bachelor’s Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience. Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Knowledge of microbiology and regulatory requirements preferred. Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation. Experience working in a GMP regulated environment preferred. Audit experience preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible toparticipatein our short-term incentiveprograms. Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other formofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr