What are the responsibilities and job description for the Specialist, Document I position at ABBVIE?
- Responsible for maintaining an accurate, cGMP compliant documentation change control system.
- Assign Change Request number for document or data changes
- Open corrective action tickets for Doc Control systems or document problems
- Review, edit and process changes to controlled documentation such as procedures,manufacturing records, forms etc. in an electronic document management system.Proofread own work and backup as a proofreader as needed. Route documents for approval.
- Ensure proper approvals have been obtained prior to final release of document andcoordinate effective dates with departments
- Maintain tracking and distribution of controlled documentation.
- Maintain master and historical document files and assist audits as required.
- Preparation of records (BR, SR, WS) for issuance to production
- Coordination and maintenance of the periodic review system
- May perform scanning of records/documents/notebooks and filing for document retention
- High School Diploma to ensure basic skills and knowledge of the job requirements and provide the minimal skills needed
- Working knowledge of cGMP regulations and industry documentation standards.
- Strong ability to communicate verbally and in writing with all levels.
- Strong Microsoft Office knowledge base (with emphasis on MS Word and MS Access).
- Exceptional organizational skills.
- Ability to manage multiple tasks and prioritize accordingly
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.
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