Celltrion Inc · 9 hours ago
Document Control Associate
Branchburg, NJ
Full-time
Hybrid
Mid Level
$71K/yr - $116K/yr
4+ years expCelltrion Inc is a company in the pharmaceutical industry, and they are seeking a Document Control Associate to assist in the development and maintenance of Document Control systems. The role involves ensuring compliance with FDA regulations, managing documentation processes, and participating in cross-functional projects.
Health CarePharmaceutical
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
Qualification
Required
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
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
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
Company
Celltrion Inc
Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase