Quality Assurance (QA) Document Control Specialist III
4410 Rosewood Dr Pleasanton, CA 94588 US
General Position Summary/Purpose: Assists in maintaining a compliant, efficient Quality Assurance Document Management program.
Key Accountabilities/Core Job Responsibilities: Performs duties in support of Quality Management System integration activities: gap assessment from current documents to new requirements; transferring of documents to new templates; managing document numbering schemes and tracking SOP updates. Support records management procedures, including scanning, filing and validation of true copies. Support regulatory inspections.
Qualifications: High school diploma with 8+ years of general document control experience. 0-2 years of pharmaceutical experience in a GMP environment. 0-2 years experience using and administering electronic document management tools. General knowledge of electronic documentation systems, data retrieval, and electronic file formats. Working knowledge of Quality Systems, GMP-related requirements and ISO guidelines, desirable. Detail oriented with solid problem solving acumen. Ability to work effectively in a team environment. Ability to analyze and reconcile moderately complex issues. Must have demonstrated initiative and accountability in a fast paced environment. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e. Microsoft Office products).