Senior Quality Engineer

Job Description 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. 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 List up to 10 main responsibilities for the job. Include information about the accountability and scope. 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. Qualifications Bachelor's degree, preferably in Biology, Chemistry or Engineering 6+ years of overall experience in Manufacturing, Quality or Engineering Good verbal and written communication skills. Good problem solving and analytical skills Good interpersonal relations / communications skills Good negotiation skills Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing. Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues