Documentation Specialist I

Job Description

Job Description

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.
• 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.

Excited to build something meaningful together? We look forward to hearing from you.

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.