Specialist, Documentation
AbbVie Ver todas las vacantes
- Barceloneta, PR
- Permanente
- Tiempo completo
- Verify and receive documents. Notify users of possible changes in documents.
- Process documents in the Documentation System. Add / revise document properties. Establish document effective dates. Approve documents and properties in the document management system and release for distribution.
- Route change request packages for review and approval, monitor responsiveness of approvers and assure appropriate approvals obtained. Communicate with initiator and customer for status updates and if implementation period needs to be negotiated.
- Complete work according to established priorities, policies, practices, and procedures to assure product documentation is delivered on schedule.
- Verify and coordinate changes to synchronize with operational systems, documentation system and ABC plant when documents are shared.
- Execute and/or verify SAP and/or DSP changes.
- Determine and implement problem solving and corrective actions related to department and documentation processing activities.
- Train employees on change control process.
- Prepare/revise manual PCRs to be used in the manufacturing areas. Manage record retention room and coordinate transfer of documents to Iron Mountain supplier.
- Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.”
- Associate Degree in Business Administration or Natural Sciences preferably, with three (3) years of experience in documentation control.
- High School Degree or GED with five (5) years of experience in documentation control.
- Five (5) years of experience in pharmaceutical industry, preferred.
- Knowledge of computerized procedures system. Knowledge of Good Manufacturing Practices.
- Computer system knowledge in Microsoft Word, Excel and SAP.
- Good verbal and written communication skills in English and Spanish. Ability to work with multiple priorities with minimal supervision. Ability to lead work groups and achieve the effective performance of tasks.