Documentation Specialist I

Validation-; Barceloneta (PR); Presencial; USD 28.000 - 42.000; Jornada completa

Descripción de la vacante

Validation & Engineering Group, Inc. in Barceloneta, PR seeks a Documentation Specialist I to manage documentation workflows across SAP, LIMS, MES/POMS, and DSP systems. You will approve and release documents, circulate change controls, and ensure timely compliance with procedures.

The role requires bilingual English/Spanish proficiency, strong MS Office skills, and experience with manufacturing/document control. Training on 1st shift and possible extended hours are available.

Formación

• Associate Degree in Secretarial Sciences, Business Administration, or Natural Sciences, with three years of experience.
• Circulates change control packages for review and approval, monitors approvers' responses, and ensures that all necessary approvals are obtained.
• Prepares/reviews manual PCRs for SVP and BDS areas.
• Manages the retention room and coordinates the transfer of documents to Iron Mountain.
• Verifies the impact of procedural changes on SAP, LIMS, MES/POMS, Delta.
• Experience in direct process/manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Available to work Training on 1st shift & after Shift: 10:30 AM to 7:00 PM.
• Available to work extended hours, weekends and holidays.

Responsabilidades

• Processes documents received by the department through the Documentation System.
• Approves documents and properties in the documentation system and releases them for distribution.
• Circulates change control packages for review and approval, monitors approvers' responses, and ensures that all necessary approvals are obtained.
• Completes work according to established priorities, policies, practices, and procedures to ensure documentation is submitted according to schedule.
• Verifies the impact of procedural changes on different operational systems such as SAP, LIMS, MES/POMS, and Delta V.
• Verifies the synchronization of changes between operational systems and documentation.
• Coordinates changes between documents shared by the Worcester and Singapore plants.
• Receives, evaluates, and assigns effective dates to documents.
• Communicates the status of procedures and CRs to initiators and negotiates implementation periods when necessary.
• Proofreads documents received by the documentation department.
• Verifies and receives documents. Notifies affected departments and the Training department of generated changes.
• Executes changes in SAP and DSP operational systems.
• Troubleshoots conflicts within the Documentation System or operational systems.
• Prepares/reviews manual PCRs for use in the SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
• Manages the retention room and coordinates the transfer of documents to Iron Mountain.
• Provides operational support in accordance with Environmental, Health, and Safety (EH&S) management systems and promotes continuous improvement.

Conocimientos

Bilingual English/Spanish

MS Windows

MS Office

Documentation/Quality

Educación

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

Herramientas

SAP

LIMS

DeltaV

DSP

Documentation System

Descripción del empleo

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Documentation Specialist I

Responsibilities:

• Processes documents received by the department through the Documentation System.
• Approves documents and properties in the documentation system and releases them for distribution.
• Circulates change control packages for review and approval, monitors approvers' responses, and ensures that all necessary approvals are obtained.
• Completes work according to established priorities, policies, practices, and procedures to ensure documentation is submitted according to schedule.
• Verifies the impact of procedural changes on different operational systems such as SAP, LIMS, MES/POMS, and Delta V.
• Verifies the synchronization of changes between operational systems and documentation.
• Coordinates changes between documents shared by the Worcester and Singapore plants.
• Receives, evaluates, and assigns effective dates to documents.
• Communicates the status of procedures and CRs to initiators and negotiates implementation periods when necessary.
• Proofreads documents received by the documentation department.
• Verifies and receives documents. Notifies affected departments and the Training department of generated changes.
• Executes changes in SAP and DSP operational systems.
• Troubleshoots conflicts within the Documentation System or operational systems.
• Prepares/reviews manual PCRs for use in the SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
• Manages the retention room and coordinates the transfer of documents to Iron Mountain.
• Provides operational support in accordance with Environmental, Health, and Safety (EH&S) management systems and promotes continuous improvement.

Qualifications:

• Associate Degree in Secretarial Sciences, Business Administration, or Natural Sciences, with three (3) years of experience.
• Circulates change control packages for review and approval, monitors approvers' responses, and ensures that all necessary approvals are obtained.
• Prepares/reviews manual PCRs for use in the SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
• Manages the retention room and coordinates the transfer of documents to Iron Mountain.
• Verifies the impact of procedural changes on different operational systems such as SAP, LIMS, MES/POMS, Delta.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Available to work Training on 1st shift & after Shift: 10:30 AM to 7:00 PM.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.