Senior Engineer, Quality

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          "text": "<p>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.<br>\nSupports 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.</p><p>Responsibilities</p><ul><li>Responsible for implementing and maintaining the effectiveness of the Quality System.</li><li>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.</li><li>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.</li><li>Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.</li><li>Participates on the Validation Review Board as the Manufacturing Quality Assurance function.</li><li>Approves standard operating procedures; ensures procedures comply with policy and make sense.</li><li>Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.</li><li>Auditing of commissioning and validation documentation.</li><li>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.</li><li>For specific U.S. manufacturing sites, performs batch release.</li></ul>",
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          "text": "<ul><li>Bachelor's degree, preferably in Biology, Chemistry or Engineering</li><li>6+ years of overall experience in Manufacturing, Quality or Engineering</li><li>Good verbal and written communication skills.</li><li>Good problem solving and analytical skills</li><li>Good interpersonal relations / communications skills</li><li>Good negotiation skills</li><li>Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.</li></ul><p><strong>Preferred </strong></p><ul><li>Experience in manufacturing within&#xa0;pharmaceutical, medical device, biotechnology and food industry with cGMP&#xa0;is&#xa0;<strong>highly desirable</strong></li><li>Experience with <strong>Risk Management Files</strong> including <strong>FMEAs </strong>is <strong>highly desirable</strong></li><li>Experience with <strong>Process Validation</strong> and <strong>Equipment</strong> with ability to validate <strong>Large Process</strong> <strong>Changes</strong>, <strong>New Products</strong> and <strong>New Custom Equipment</strong> is <strong>highly desirable</strong></li></ul>",
          "title": "Qualifications"
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          "text": "<p><strong>About AbbVie</strong></p><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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&#xa0;<a href=\"http://www.abbvie.com/\" rel=\"noopener noreferrer\">www.abbvie.com</a>. Follow @abbvie on&#xa0;<a href=\"https://www.linkedin.com/company/abbvie/\" rel=\"noopener noreferrer\">LinkedIn,</a>&#xa0;<a href=\"https://www.facebook.com/AbbVieGlobal/\" rel=\"noopener noreferrer\">Facebook</a>,&#xa0;<a href=\"https://www.instagram.com/abbvie/\" rel=\"noopener noreferrer\">Instagram</a>,&#xa0;<a href=\"https://twitter.com/abbvie\" rel=\"noopener noreferrer\">X</a>&#xa0;and&#xa0;<a href=\"https://www.youtube.com/user/AbbVie\" rel=\"noopener noreferrer\">YouTube.</a></p>",
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          "text": "<p>​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&#xa0;local law:&#xa0;​</p><ul><li>The compensation range described below is the range of possible base pay compensation that the Company&#xa0;believes in&#xa0;good faith it will pay for this role at the&#xa0;time&#xa0;of&#xa0;this posting based on the job grade for this position.&#xa0;Individual&#xa0;compensation paid within this range will depend on many factors including geographic&#xa0;location,&#xa0;and&#xa0;we&#xa0;may&#xa0;ultimately&#xa0;pay&#xa0;more or less than the posted range. This range may be&#xa0;modified&#xa0;in the&#xa0;future.&#xa0;​</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&#xa0;medical/dental/vision&#xa0;insurance and 401(k) to eligible&#xa0;employees.​</li><li>This job is eligible to&#xa0;participate&#xa0;in our short-term incentive&#xa0;programs.&#xa0;​</li></ul><p>Note: No amount of pay&#xa0;is considered to be&#xa0;wages or compensation until such amount is earned, vested, and&#xa0;determinable.&#xa0;The&#xa0;amount&#xa0;and&#xa0;availability&#xa0;of &#xa0;any&#xa0;bonus,&#xa0;commission, incentive, benefits, or any other form of&#xa0;compensation and benefits&#xa0;that are allocable to a particular employee&#xa0;remains&#xa0;in the Company's&#xa0;sole&#xa0;and&#xa0;absolute&#xa0;discretion unless and until paid and&#xa0;may be&#xa0;modified&#xa0;at the Company’s sole and absolute discretion, consistent with&#xa0;applicable law.&#xa0;​</p><div sr-tagline=\"\"></div><p>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.&#xa0;</p><p>US &amp; Puerto Rico only - to learn more, visit&#xa0;<a href=\"https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a></p><p>US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p><a href=\"https://www.abbvie.com/join-us/reasonable-accommodations.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/reasonable-accommodations.html</a></p>",
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