Documentation Specialist I

Documentation Specialist I - PR

Work Location: KM 58.0 State Road No. 2 Barceloneta PRI 00617

Special Responsibilities:

• Process through the Documentation System the documents that arrive at the area.
• Verify the impact of changes to procedures on different operational systems such as SAP, LIMS, MES / POMS, Delta V.
• Verify the synchronization of changes in operational and documentation systems.
• Coordinate changes between documents shared by Worcester, ABL and Singapore plants.
• Carry out "troubleshooting" to the system when necessary.
• Train employees in the techniques of the system.
• Receive, evaluate, and assign the effective date of specifications.
• Manages reports of "status" of procedures and "CR's".
• It carries out "proofreading" of the documents that arrive at the documentation area.
• Approve documents in the documentation system.
• Record the "Effective Date".
• Notify the affected areas and the "Training" department of the changes generated.
• Prepare documentation metric reports as required.
• Execute changes in the operational systems of SAP and DSP.
• "Troubleshooting" of conflicts in the Documentation system or operational systems.
• Verify divisional documents that are received and notify users of possible changes in plant documents.
• Maintain the folder of official copies controlled in the manufacturing areas.
• Replace PCRs with the effective version and destroy the previous version of PCR's.
• Prepare / Review manual PCR's to be used in the SVP (Small Volume Parenteral) area.
• Scan the documentation of the SVP approved batches and upload them to the Documentation system.
• Provide assistance to operations in accordance with Environmental, Occupational Health and Safety (EH&S) management systems and promote continuous improvement.

Education:

• Associate Degree in Secretarial Sciences, Business Administration or Natural Sciences.

Experience:

Mention the minimum experience requirements necessary. Please include the titles

• Experience in documentation control - Minimum of five (5) years.

Work Environment, Work conditions, frequency:

Continuously interacts with the different departments of the plant, eg. Validation, Training, Quality, Production, Engineering, IS, etc., at levels of non-exempt personnel up to the plant management and with representatives of Documentation in Worcester and Division

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