Job Description

Title: Documentation Specialist

Location: Pennington, NJ - must work onsite 5 days a week

Pay Rate: 20-25/hr

Type: Contract

Duration: 4 months

This position is a full time, on site position for a period of 4 months. It will be responsible for providing document management expertise.

Position Overview

The Document Control Specialist is primarily responsible for managing and maintaining the records required to support the Quality Management System, including product and product development, and business activities. The Document Control Specialist will also support the Quality and Regulatory team by performing general quality system activities.

Key Responsibilities

Manage the day to day operations in assigned area of Document Control.

Issue working records for production and QC.

Archive completed, scanned records

Manage True Copy activities

Implement new document archive procedures. This could include writing procedures as well for True Copy scans, etc.

Manages document control processes and systems for GMP activities in compliance with internal procedures and policies.

Maintains the lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval, retention and destruction.

Control of other manual GMP processes such as logbooks.

Participate in the maintenance and continuous improvement of the Document Management System (DMS)

Work with team members to ensure technical documentation is complete and reflect current practice

Technical review of applicable procedures in Master Control.

Support customer and internal audits.

Other duties as assigned.

Qualifications

Education: Bachelor in a Life Science discipline or equivalent (4+ yrs industry experience).

Experience: minimum of 2 years of experience in direct control of GMP systems and documentation.

Skills: Knowledge of GMP’s, FDA regulations and documentation procedures required. Proficiency/knowledge with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc). Proficient with MS Office applications and Adobe Acrobat. Must have experience with growing and fast paced environments.

Communication: Exceptional verbal, written, and interpersonal communication skills. Comfortable and able to operate in a multi-cultural environment. Able to communicate activity status to Quality Assurance leadership. Able to explain application of cGMP regulations, quality systems and regulatory requirements for documentation system. Able to work in an open office environment. Excellent written and verbal communication skills. This covers the ability to communicate clearly and professionally across multiple channels. Must demonstrate the ability to listen intently to understand and process information.

Physical Demands

Must be able to sit and stand for an entire shift and will usually remain in a stationary position throughout the shift.

Will use repetitive motion of the hands, wrists, or fingers, such as typing.

This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work

This job operates in an office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets

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