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Specialist, QA

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Westport, MO

  1. Operations
  2. Quality Assurance
  1. Full-time
R00102707

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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

At AbbVie, we stand for people, passion and possibilities. It's our belief in these three essential components that allows us to create medicines and solutions that make a real difference in people’s lives. 


Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives worldwide. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact felt within healthcare and beyond.


We are now recruiting a QA Specialist at our Westport site on a full time basis.


In your new role you will hold responsibility for QA support of all aspects of commercial, clinical and development activities in relation to Visual Inspection activities at the site and also hold responsibility for all IQA activities for the introduction of all new product contacting commodities.


So, if you are ready to make a significant impact with your next role and want to be part of an exciting team, read on to find out more and get your application started today!


Your main responsibilities will be:


  • QA oversite and support for the implementation of the site Visual Inspection Program.

  • Implementation of incoming inspection plans for all new product contacting commodities.

  • Coordinate and investigate quality events such as CAPA, complaints relating to defects or particulate contamination and corresponding action plans.  

  • Maintenance of Quality System Records (e.g. CAPA, Change Controls, Opportunity for Improvements) to ensure accurate and timely closures.

  • Assist with the review and comparison of new/unusual/AQL particulate defects found during routine production.

  • Control and Maintenance and replacement of approved qualification, back-up and automated defect sets.

  • Oversite and Review/Approval of Visual Inspection Qualification and Re-Qualification Reports.

  • Oversite and review and approval of Visual Inspection action limits and trending 


Qualifications

For this role you will need the following; 


Education and Technical Skills - 


  • Third level qualification in a science, quality, or relevant discipline.

  • Minimum of two years’ experience in a quality role in a Pharma/Med Device industry

  • Strong knowledge of regulatory requirements is required.

  • High level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times

  • Proven problem-solving skills and the ability to adapt to new regulatory requirements

  • Results driven and accountable striving to meet all targets and metric standards as set by site/department and division leaders

  • Strong communication skills both verbal and written are required for the execution of this role


So, if all this sound like the right role for you, then apply today!


AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.


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.

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