Job Title: Documentation Specialist I
Location: Barceloneta, PR 00617
Duration: 12+ months (possible extension)
Pay Rate: $17.74/hr
Shift: 10:30 AM – 7:00 PM
Must be available to work overtime and weekends based on business needs.
General Position Summary/Purpose:
The Documentation Specialist is responsible for managing documentation processes, ensuring documents are reviewed, approved, controlled, and distributed according to established procedures and timelines.
Key Responsibilities:
- Process documents received by the department through the Documentation System.
- Add and review document properties.
- Approve documents and document properties within the documentation system and release them for distribution.
- Route change control packages for review and approval, monitor approver responses, and ensure all required approvals are obtained.
- Complete assigned work according to established priorities, policies, practices, and procedures to ensure documentation is submitted according to schedule.
- Verify the impact of procedural changes on various operational systems such as SAP, LIMS, MES/POMS, and DeltaV.
- Verify synchronization between changes made in operational systems and documentation systems.
- Coordinate document changes shared between the Worcester, ABL, and Singapore sites.
- Train employees on documentation system procedures and techniques.
- Receive, evaluate, and assign effective dates for documents.
- Communicate the status of procedures and Change Requests (CRs) to document initiators and negotiate implementation timelines when necessary.
- Perform proofreading of documents submitted to the Documentation department.
- Verify and receive documents; notify impacted departments and the Training department about generated changes.
- Execute changes within operational systems such as SAP and DSP.
- Troubleshoot conflicts within the Documentation System or operational systems.
- Prepare/review manual PCRs (Process Change Requests) for use in SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
- Manage the retention room and coordinate document transfers to Iron Mountain.
- Provide operational support related to Environmental, Health & Safety (EH&S) management systems and promote continuous improvement.
Education Requirements:
- Associate Degree in Secretarial Science, Business Administration, or Natural Sciences with three (3) years of experience. OR
- High School Diploma/GED with five (5) years of documentation control experience.
Experience Requirements:
- Minimum of three (3) years of experience in document control/documentation management.
- Experience working in a documentation control environment.
Work Environment:
- Office-based environment.
- Continuously interacts with various plant departments, including:
- Validation
- Training
- Quality
- Manufacturing/Production
- Engineering
- Information Systems (IS)
- Other departments
- Communicates with employees ranging from non-exempt personnel to plant management and Documentation representatives at Worcester and division levels.
Top Skills Required:
- Process documents through the Documentation System.
- Verify the impact of procedural changes on operational systems such as SAP, LIMS, MES/POMS, and DeltaV.
- Verify synchronization between operational system changes and documentation updates.
- Perform proofreading of documents received by the Documentation department.
- Prepare and review manual PCRs for SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
- Manage the retention area and coordinate document transfers to Iron Mountain.
- Experience working in a documentation control environment.
- Strong Client Word skills.
- Experience with batch documentation preparation.
- Experience working in a document retention area.
Top 3–5 Required Skills, Experience, or Education:
- Experience processing documents through a Documentation Management System.
- Experience managing change control packages, routing documents for approvals, and tracking approval status.
- Experience preparing/reviewing PCRs for SVP and BDS manufacturing areas.
- Experience managing document retention processes and coordinating transfers to Iron Mountain.
- Experience verifying procedural changes and impacts across systems such as SAP, LIMS, MES/POMS, and DeltaV.
Nice-to-Have Skills (Not Required):
- Knowledge of AttachePro.
- Strong proficiency in Client Word and Excel.
- Bilingual in English and Spanish.