Document Control Coordinator

The Documentation Coordinator I is responsible for the control of Quality Management System (QMS) and qualityspecific GMP critical documentation.

• Ensuring that document reviews and approvals are managed in an efficient and effective manner.
• Ensuring that all records of document status, outstanding change controls, document reviews, and document approvals are meticulously maintained.
• Ensuring that documents comply with established templates, formats, and identification naming/numbering standards.
• Ensuring that document crossreferences are accurate and traceable.
• Maintaining the electronic document library and developing and/or maintaining a QMS document inventory that includes relevant information regarding document identification, status, effective dating, and other pertinent document control information, as required.
• Managing and controlling specific quality records, as required.
• Distributing and removing controlled documentation to/from points of use, as required.

1. Bachelors degree OR a high school education and a minimum of 3 years experience in a GMP controlled environment.
2. Experience using document control strategies or methods in a GMP controlled environment.
3. Knowledge of MS Office products as well as the ability to learn new systems as required.
4. Ability to communicate using English.
5. Prior experience using word processing, spreadsheet, and presentation software.

• Distributing controlled documents (procedures, specs) to the Production floor and other points of use.
• Sorting, filing, and maintaining controlled documents and other Quality Records (e.g. TRVs, DHRs) in Document Control room.
• When necessary, coordinate offsite storage activities.
• Process requests for copies of controlled documents and Quality Records.