Senior Specialist, Document Management, R&D QA
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.
Primarily responsible for managing and supporting change control related activities for supported Quality Documentation including document formatting, maintenance of document properties and facilitation of review and approval workflows. Furthermore, acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between RDQA QS Documentation Management group and supported R&D functions.
- Ensures all administrative documentation requirements are met for supported Quality Documentation
- Maintains notifications, relations and other property information within the Document Management System (DMS)
- Facilitates administration, review and approval (as applicable) of new and revised Quality Documentation within the DMS
- Participates in continuous improvement projects related to documentation management as applicable
- Supports and coordinates of translation process (incl. Translation checking (LU only) as applicable
- Supports Change Control activities for shared Quality System Documents
- High School diploma or equivalent, OR Associate’s degree with minimum of 3+ years experience in pharmaceutical industry (production and/or quality assurance) or related field required
- Bachelor’s degree, OR Completed technical / commercial education (OUS), preferred
- Basic understanding and knowledge of GxP requirements and pharmaceutical regulations
- Advanced Knowledge and hands-on experience with Document Management Systems OR other database applications
- Experience in detail-intensive and customer-focused work environments
- Advanced organizational skill, attention to detail
- Advanced oral and written communication skills
- Experience with Microsoft Office products, incl MS Word processing / formatting experience
- Advanced spoken and written English skills (OUS only)
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.