Document Management Specialist
Location: Houston
Type: Full time, permanent
Schedule: Hybrid
Salary: Commensurate with experience
Position Responsibilities
- Responsible for managing the documents in the eQMS system and performing tasks to ensure optimal operations of document review and approval within the system for all Marker personnel
- Managing and maintaining the document storage system for both electronic and hard copy files at Marker's GMP facility.
- Perform a quality check of each document as it is approved for release in the QMS and verify the correctness of formatting, styles and compliance with company standards
- Manage and track non-conformance events, deviations, CAPAs in the electronic QMS.
- Preparing documents for the manufacturing group to support the production activities for Marker's products.
- Create training courses and manage training activities for all personnel in the electronic QMS
Skills, Education and Experience Required
- Bachelor's degree
- Minimum of 5-10 years of experience in document management in the Pharmaceutical industry
- Experience using electronic document management software systems
- Working knowledge of GMPs in conformance to U.S. standards (21 CFR 210/211, 600, 810 and 1271).
- Experience with Change Control practices/strategies