Document Control Associate

Celltrion Branchburg, LLC • Branchburg Township, NJ

15h • $71,250 - $116,000 • Hybrid

About The Position

This Document Control role assists in the development, optimization, and maintenance of Document Control systems to ensure compliance with FDA regulations and company policies and procedures. This role represents Document Control in QA Initiatives and Cross Functional projects. Additionally, this role is responsible for the review, routing, distribution and filing of GXP documentation. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite. Physical movement of document files/boxes is required; must be able to lift 30 pounds.

Requirements

• A bachelor’s degree is required.
• 4 to 5 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required; specific GXP-regulated documentation control experience is required.
• Thorough knowledge of Document Management practices and principles in a Corporate and GMP environment.
• Thorough knowledge of computer applications in the Microsoft Office Suite.

Responsibilities

• Participate in department optimization efforts; take the lead on selected projects and assignments, following them through to closure.
• Represent Document Control on selected cross-functional projects and initiatives.
• Assist in the coordination of Document Control activities in a specified Documentation Center location.
• Update departmental Standard Operating Procedures as needed.
• Provide technical assistance throughout the document initiation, review, and approval process.
• Prepare and route documentation packages throughout review and approval cycle.
• Assist in departmental related internal audits, NCE investigations and corrective actions.
• Track document approval activities in electronic tracking system; ensuring on-line e-library is updated and accurate.
• Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices.
• Initiate and track periodic Documentation Binder Audits to assure documentation in the field is current and complete.
• Issue controlled Production Documentation to Manufacturing and Laboratory Notebooks to cross functional areas; maintain records of issuance.
• Label and code files for storage in on-site Documentation Centers.
• Always ensure ethics and compliance commitment. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.

Benefits

• paid time off (holidays, vacation, and additional leave)
• medical, dental, and vision insurance
• life insurance
• a company-matched retirement savings plan
• wellness programs
• short- and long-term disability benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level