DOCUMENTATION SPECIALIST

Documentation Specialist

Location: Pennington, New Jersey

Category: Other

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description Target Pay Rate: 20-25/hr **salary will be commensurate with experience Reports to: Associate Director QMS

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

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

Fraud Alert

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.