AL
Documentation Specialist
Artech LLC
🇵🇷 Puerto Rico
On-site
Staff / Principal
1 week ago
- Change Management
- SAP
- Excel
1 week ago
Job duration: 12+ months
Job location: Barceloneta, PR
Shift: 10:30 am - 7 pm
Must be available to work overtime and weekends based on business needs
Documentation Specialist
- Processes documents received in the area through the Document Management System.
- Adds/reviews document properties in the system.
- Approves documents and system properties and releases them for distribution.
- Circulates change management packages for review and approval, monitors approver responses, and ensures all required approvals are obtained.
- Completes work according to established priorities, policies, practices, and procedures to ensure documentation is issued per schedule.
- Verifies the impact of procedural changes on various operational systems such as SAP, LIMS, MES/POMS, and DeltaV.
- Verifies synchronization of changes between operational systems and documentation systems.
- Coordinates document changes across shared sites (Worcester, ABL, and Singapore plants).
- Trains employees on system techniques and procedures.
- Receives, evaluates, and assigns effective dates for documents.
- Communicates status of procedures and change requests (CRs) to initiators and negotiates implementation timelines when necessary.
- Performs proofreading of documents received by the documentation area.
- Verifies and receives documents, notifies affected areas and Training department of changes.
- Executes changes in operational systems such as SAP and DSP.
- Troubleshoots conflicts in the Document Management System or operational systems.
- Prepares/reviews manual PCRs for use in SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
- Manages the retention room and coordinates document transfer to Iron Mountain.
- Supports operations in Environmental, Health & Safety (EH&S) systems and promotes continuous improvement.
Education Requirements
- Associate degree in Secretarial Sciences, Business Administration, or Natural Sciences with 3 years of experience, OR
- High school diploma or GED with 5 years of experience in document control.
Experience Requirements
- Minimum of 3 years of experience in document control.
Work Environment
- Physical: Office environment
- Social: Continuous interaction with multiple departments such as Validation, Training, Quality, Production, Engineering, IS, etc.
- Interacts with staff from non-exempt level to plant management, as well as documentation representatives from Worcester and the division.
Intake Call Requirements
Required Experience / Education
- Minimum 3 years of experience in QA documentation OR Associate/Bachelor’s degree.
Top Skills Required
- Processing documents through a document management system.
- Circulating change management packages and ensuring required approvals are obtained.
- Preparing/reviewing manual PCRs for SVP and BDS areas.
- Managing document retention room and coordinating transfers to Iron Mountain.
- Verifying impact of procedural changes on systems such as SAP, LIMS, MES/POMS, DeltaV.
Additional Skills (Nice to Have)
- Knowledge of AttachePro
- Strong proficiency in Client Word and Excel
- Bilingual (English/Spanish)
Work Environment Type
- Combination of individual and group work settings
Documentation Specialist · Artech LLC