Quality Engineer IV- Data Integrity
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This position performs as QA partner with Business Technology and has the responsibility to drive compliance improvements identified in the Waco site’s Action Plan, relating to electronic systems compliance across the manufacturing network.
This position is responsible for the following:
• Maintaining a program to comply with the requirements of the FDA, EU and ISO 13485:2003, and other relevant regulatory bodies for the site.
• Provide direct oversight to local manufacturing and laboratory system across multiple sites related to Change Control and System functionality
• Establish and manage system control oversight.
• Serving as SME for electronic system compliance in support of inspection readiness activities.
• Overseeing investigation and corrective actions for non-conformances related to supplier quality, manufacturing and packaging, and support quality investigations outside of these areas as needed.
• Working closely with site management, peers and colleagues to ensure that quality representation is activity engaged in facility and capital project initiation and execution.
• Providing electronic system compliance expertise to the revision of the DH/DI standard and to provide recommendations regarding DH/DI training materials.
• Ensuring commissioning and validation activities are in-compliance with industry and site procedures.
• Leading and participating in continuous improvement initiatives as appropriate.
• Managing the change control processes for the site.
• Providing QA support of FDA or other regulatory inspections.
• Ensuring community of practice for DH/DI governance for electronic and hard copy data systems.
• Supporting corporate initiatives as necessary.
Education and Experience:
- Minimum of a B.S. in Engineering, Computer Science, or Information Technology, or sciences degree from an accredited institution; Graduate degree is preferred. An Associate’s Degree with a combination of relevant work experience may be considered for substitution for the degree requirement.
- Minimum of Seven (7) years of experience with a minimum of Four (4) years working in relevant areas such as process validations or technology transfer or laboratory data control. A Master’s Degree may substitute for one year of experience.
- Experience in a GMP regulated environment preferred.
Essential Knowledge, Skills & Abilities:
- Ability to communicate accurately and timely.
- Strong technical written and oral communication skills.
- Excellent Interpersonal skills.
- Project Management skills.
- Knowledge of Regulatory Compliance criteria established by Governmental Agencies, Boards of Health and Legislative Requirements.
- Basic knowledge of strategic and tactical issues in an operations environment.
- Demonstrated project management skills and the ability to influence others effectively.
- The individual must be result orientated and able to demonstrate the use process measurement tools to achieve metrics.
- Demonstrated process thinking skills and familiarity with knowledge management.
- Demonstrated ability to apply analytical methods.
- Demonstrated ability to work with all levels of Management.
- Demonstrated business acumen.
- Detail-oriented and self-motivated.
Significant Work Activities
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.