This is a temporary entry-level position requiring basic knowledge of document change control, quality assurance systems, methods, and procedures. Basic proficiency in application quality system principles, concepts, industry practices, and standards.
Essential duties and responsibilities include the following. Other duties may be assigned.
Knowledge, Experience and Skills:
•Ensures the correct and timely implementation of Document Change Orders (DCOs) and Documents within an electronic document management system.
•Primary responsibilities include: processing documents following defined processes/procedures, scanning, filing, indexing of GxP-related documents and records and coordination of off-site records.
•Processes Deviation and Change Request documentation. Communicates with customers to ensure changes are concise and complete.
Education & Experience:
•AA degree with 2+ years or BS with 1+ years of relevant experience in a GMP environment.
•Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs).
•Demonstrates basic knowledge of FDA/EMA standards and quality systems.
•Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
•Good verbal, written, and interpersonal communication are required.
•Demonstrates working knowledge of Microsoft Office applications (Word, Excel).