CAPA Specialist (Pipeline)

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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Join our team as a Quality Investigator and play a critical role in ensuring that our products meet the highest standards of quality and safety. As a Quality Investigator, you will be responsible for independently leading complex investigations and ensuring that all investigations are written according to corporate and site requirements. You will also have the opportunity to promote a culture of continuous improvement by identifying problems, conducting root cause analysis, and implementing corrective and preventive actions.

If you are passionate about quality and want to make a meaningful impact in a dynamic and collaborative environment, we encourage you to apply.

Responsibilities:

• Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
• Coordinates the exception document process and creates exception documents
• Independently leads complex, high impact investigations
• Ensures all investigations are written according to corporate and site requirements
• Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
• Ensures all Quality CAPA goals and metrics are met
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
• Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant

Qualifications

• Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering
• 6+ years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering
• Previous experience in quality assurance or quality control within the biotech or pharmaceutical industry
• Knowledge of Quality/Compliance management, Regulations and Standards
• Strong understanding and experience in CAPA management and related areas (deviation management, change control, risk management)
• Demonstrates ability to problem solve and utilize analytical skills

Additional Information

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 and long-term incentive programs.

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.