As a Document Management Specialist, you will be part of the Quality Team responsible for performing the activities to support of Marker's Quality Management System and maintain compliance with current Good Manufacturing Practices and ISO 9001:2015. This position will require to working collaboratively with all departments to manage and maintain controlled documents electronic forms and personnel training within the company's electronic quality management system (eQMS).
Location: Bryan, TX
- Responsible for managing the documents in the eQMS system
- 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
- 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
- Update and validate the electronic QMS in accordance with MasterControl and Marker's computer system validation (CSV) procedures and requirements.
- Review changes to validated state of system through change control and manage the review and implementation of the proposed changes
- 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
- Expertise in Outlook, MS Word, Excel, Power Point, Adobe Acrobat Professional and other software applications