Senior Quality Engineer

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.

Responsibilities

• Implement and maintain 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.
• Ensure investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system.
• Perform product impact analyses for plant events and place product on QA hold where appropriate.
• Maintain an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures; ensure procedures comply with policy and make sense.
• Approve calibration requests and ensure that these requests have appropriate product/process limits assigned.
• Audit commissioning and validation documentation.
• Develop product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs.
• Develop and implement statistical quality programs and process monitoring systems.
• For specific U.S. manufacturing sites, perform 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/communication skills.
• Good negotiation skills.
• Knowledge of quality/compliance management as well as regulations and standards affecting API, Bulk Drug, or Finished goods manufacturing.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.

Pay

The compensation range for this role is based on the job grade and may vary depending on geographic location and other factors. The range may be modified in the future.