Quality Systems Analyst
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.
The primary responsibility of this position is assisting in the maintenance of the Quality System including the Corrective Action/Preventative Action (CAPA) process, Internal/External Audit process, and overall Quality System Compliance.
Specific responsibilities include preparing and analyzing data, preparing / scheduling internal and external audits, overseeing of the maintenance of the CAPA and Internal/External Audit files and facilitating the timely completion/approval of root cause investigations, closure, and verification of effectiveness.
Assists in review of CAPA and/or Internal Audit systems root cause investigation and corrective action planning.
This position also requires the involvement in continuous improvement opportunities associated with the Quality System; the ability to manage project tasks and timelines and work with cross-functional teams to drive implementation.
KEY DUTIES AND RESPONSIBILITIES:
- Interfaces with cross-functional teams on a daily basis to drive timely completion of CAPA and Internal/External audit activities i.e. root cause investigations and completion of action plans
- Assists in review of CAPA and/or Internal Audit responses, root cause investigation and corrective action planning
- Assists in audit planning and execution of Internal Audits as a Lead Auditor, as necessary
- Involvement in continuous improvement opportunities associated with the Quality System
- Support External Audits; audit preparation, and may act as a subject matter expert or in back room or front room audit support activities
- Assists in planning, scheduling, coordination, execution of Quality Management Review
- Reviews and analyzes information for trending/risk analysis and corrective action to ensure effectiveness of actions
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
- Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical) or equivalent preferred
- Minimum of 2 years of quality systems experience in FDA regulated medical device manufacturing environment(s)
- Experience with preparing and analyzing data (i.e. CAPA/Internal Audit, Complaint and NCMR timeliness etc.)
- Knowledge of QSR, ISO13485, ISO14971, EU MDR and additional MDSAP country requirements preferred
- Certified Lead Quality Auditor preferred
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook
Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
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.