Document Control Analyst at Mallinckrodt Pharmaceuticals in Bedminster, New Jersey

Posted in Other 3 days ago.

Job Description:

Job Title

Document Control Analyst


JR000011665 Document Control Analyst (Open)


US Specialty Brand Headquarters - USA501

Additional Locations

Hampton, NJ

Job Description


This position establishes and performs document control processes to ensure that controlled documents are revised, approved, distributed, and archived using Master Control.

Essential Functions

  • Manage the document control process in Master Control.

  • Review Document Change Controls for completeness and correctness. Ensure that appropriate approvers are specified. Collaborate with change originators to resolve discrepancies.

  • Perform final formatting on revised documents to ensure accurate incorporation of redline revisions.

  • Promote approved documents to effective upon completion of required training and any change control requirements.

  • Monitor the periodic review process of controlled documents for timely completion.

  • Train new users when required in the use of the Master Control Document Control module.

  • Maintain user profiles with appropriate access rights.

  • Communicate any EDMS issues with Master Control.

  • Serve as the subject matter expert to end users of the Master Control Document Module.

  • Manage the relationship between document change controls and change controls.

  • Manage document reports.

  • Support all regulatory audits and inspections.

Minimum Requirements

Education / Experience / Skills:

  • BA/BS Degree

  • 2-4 years of experience in a medical device (Class II/Class III) and/or pharmaceutical company.

  • Demonstrated knowledge, including application, of QSR/GMP (21 CFR Part 210, 211, 820) regulations, ISO/EU regulations/Standards (ISO 13485, EU MDR). Familiarity with other International Standards.

  • Experience with an electronic Quality Management System software tool such as TrackWise, MasterControl, or equivalent is required.

  • Self-motivated.

  • High attention to detail and accuracy.

  • The ability to successfully balance and prioritize multiple ongoing projects and tasks.

Organizational Relationship/Scope:

This position plays a lead role in the electronic Document Management System. Interaction with various levels of management is possible.

Working Conditions:

Normal office environment. Travel could be up to 10%.