Documentation Specialist I

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.

• Adds/reviews document properties.

• 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.

• Trains employees on system techniques.

• 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.