Document Control Specialist Role in Pharmaceutical Manufacturing

7 days ago


Berkeley Heights, New Jersey, United States Vertellus Full time
About the Role

We are seeking a highly skilled Document Control Specialist to join our team at Aurorium, a global materials innovation partner. This role is responsible for ensuring that all site documentation meets regulatory requirements and adheres to industry standards.

Key Responsibilities
  • Provide ongoing support and review of Quality System documents, including SOPs, Work Instructions, and other functional documentation.
  • Review batch records for accuracy and release for next steps.
  • Manage quality department documentation in MasterControl.
  • Write, format, and edit documents, including Standard Operating Procedures, Forms, and policies to support site operations.
Requirements
  • Bachelor's degree in a scientific discipline.
  • 5+ years of Quality Control/Quality Assurance/Document Control experience in a manufacturing plant, preferably in a cGMP regulated environment.
  • Experience with document control and records management.
  • Knowledge of regulatory requirements for active bulk pharmaceuticals (API) is a plus.
Benefits

Aurorium offers competitive total compensation packages, including benefits such as medical, dental, vision, life, 401(k), disability insurance, flexible spending accounts, health savings accounts, paid time off, and paid holidays.

Salary Range

The estimated salary for this role is $85,000 - $110,000 per year, depending on location and experience.



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