Quality Engineer

Company Description

Abb Vie'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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

In this role, an individual supports site manufacturing operations and quality by managing the approved supplier list including supplier qualification, performance, and maintenance. They help maintain and implement the company's Quality System, ensuring all activities and procedures align with company standards and regulatory requirements. The person also assists Incoming and Manufacturing QA in investigating plant events, performing product impact analyses, and managing product/material holds when needed.

They collaborate effectively with other local and global QA and Technical departments, participate as the Supplier QA in Global Supplier Center of Excellence (CoE) meetings, and approve standard operating procedures and change management actions to ensure regulatory and procedural compliance. This individual will support site compliance and regulatory audits as the subject matter expert for local supplier QA.

• Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
• 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.
• Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

• Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience
• 2+ 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.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Abb Vie 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.

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