Quality Engineer Iii

Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description

Purpose
The Quality Engineer III performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation at the Waco, Texas facility.

Responsibilities 

• 
  
  Provide Quality Assurance oversight and assessment of operational activities in Production, Compliance, Validations, and Technical Services projects.


• Serve as the QA representative on Validation and Technical Services projects.  Liaison to process and equipment validations for QA/QC laboratories, BT, Manufacturing, and Engineering.


• Ensure process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes.


• Review and approve equipment validation documentation (e.g., protocols, deviations, and final reports).


• Support change control activities associated with processes and equipment validations.


• Manage and coordinate QA support for new and existing process equipment validations implementation.


• Responsible for implementing and maintaining the effectiveness of the Quality System.


• 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 places product on QA hold where appropriate.


• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.


• Develop and implement statistical quality programs and process monitoring systems. 


• Support investigations related to process and testing findings.


• Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPA’s, compliance, complaints process.


• Perform other duties as assigned. 

Qualifications

Qualifications 

• Bachelor's degree, preferably in Biology, Chemistry or Engineering.


• 6+ years of overall experience in Manufacturing, Quality or Engineering.


• Experience in pharmaceutical GMP regulated environment preferred. 


• Experience in aseptic manufacturing environment preferred. 


• Knowledge of quality / compliance management, as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.


• Good verbal/written communication skills. Good problem solving and analytical skills.


• Demonstrated ability to apply analytical methods and work with all levels of Management. 


• Detail-oriented and self-motivated. 

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.