Document Control Associate

Job Description

Job Description

Position Brand Description:

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.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

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

General Requirements:

1. A bachelor’s degree is required.
2. 4 to 5 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required; specific GXP-regulated documentation control experience is required.
3. Thorough knowledge of Document Management practices and principles in a Corporate and GMP environment.

This role is exempt and the anticipated compensation for this role is $72,000- $145,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.