Specialist, Quality Systems

About AbbVie
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 .

Purpose:

The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilites:

• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Conduct initial regulatory review of documents.
• Assist with audits of documentation, facilities and equipment.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Support project teams in planning, preparation, review and approval of quality documentation.
• Collect and compile key quality metric data.
• Perform QA review for product release.
• Participate in training and education programs for various aspects of quality assurance.

Qualifications

Qualifications:

• Bachelor's Degree (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred) or equivalent experience.
• 0-2 years' experience in quality assurance, quality oversight or relevant experience.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological and medical device products preferred.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Delivers tactical results to support the quality system.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.