Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
1. Support GMP Facilities SOP/WP Administration operations, including individual projects and assignments, as needed.
2. Format technical document according to standard formatting and update of documents to incorporate Subject Matter Expert review comments.
3. Preparation and distribution of SOPs/WPs for signatures within electronic document management system; as well as organizing, tracking status and timelines.
4. Track GMP Facility Department Quality Management System actions and provide status updates.
5. Preparation of SOP/WP and supporting documents for submission to the Compliance Wire (training management system) Manager.
6. Responsible for maintenance of Excel spreadsheets for maintenance and tracking of SOPs/WPs.
7. Other responsibilities will include filing of equipment asset documentation and routine and demand work orders.
8. Demonstrates and promotes company values and behaviors.
Must have strong organization skills, be a team player and be willing to work in an environment where individual initiative and accountability to projects are required. Must be able to work with limited day-to-day supervision. Must have a general knowledge of SOP standards. Must have experience with record retention, archival processes. Must have experience with electronic document management systems. A business/administrative school graduate or equivalent in industry experience. Minimum 3 years document management experience.
Minimum 3 years experience in the Pharmaceutical industry preferred.
Strong PC skills to include: Microsoft Excel and Word Excellent written and oral communication skills.