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Senior Quality Engineer - Manufacturing Quality Assurance

Company: AbbVie, Inc.
Location: Clearlake
Posted on: May 3, 2021

Job Description:

Senior Quality Engineer - Manufacturing Quality AssuranceLake County, United States of America2106320Job DescriptionAbout AbbVieAbbVie'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 . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .Purpose:The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.Responsibilities:Responsible for implementing and maintaining the effectiveness of the Quality System.Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.Participates on the Validation Review Board as the Manufacturing Quality Assurance function.Approves standard operating procedures; ensures procedures comply with policy and make sense.Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.Auditing of commissioning and validation documentation.Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA's. Develops and implements statistical quality programs and process monitoring systems.For specific U.S. manufacturing sites, performs batch release.QualificationsQualifications:Bachelor's degree, preferably in Biology, Chemistry or Engineering6+ years of overall experience in Manufacturing, Quality or EngineeringGood verbal and written communication skills.Good problem solving and analytical skillsGood interpersonal relations / communications skillsGood negotiation skillsKnowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.Significant Work ActivitiesN/ATravelYes, 15 % of the TimeJob TypeExperiencedScheduleFull-timeJob Level CodeICEqual Employment OpportunityAt 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.As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you "phishing" messages.Please be alert to and protect yourself from phishing scams. Click here to find out how you can avoid being a victim of job phishing scams.SDL2017

Keywords: AbbVie, Inc., Santa Rosa , Senior Quality Engineer - Manufacturing Quality Assurance, Other , Clearlake, California

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