Documentation Manager jobs in Niagara Falls, NY

* Coordinates and processes document changes at the Production Unit level in paper-based and electronic systems.

* Coordinates document implementation and updating of controlled binder sets.

* Mainains and issues Logbooks and Lab Notebooks and ensures they are in compliance with all applicatble procedures throughout their lifecycle.Issues other controlled documents as necessary.

* Works directly with the IT Support Team to ensure cGMP/Quality data is managed according to functions of the electronic document management system.

* Assists with central filing controlled documents.

* Assures archives are orderly, complete, accurate and readily available for inspection (back up).

* Works with Compliance management team on records and reports that are subject to FDA/cGMP inspection as needed.

* Performs other duties as assigned by the QA Supervisor/Manager and/or other Quality Management

Requirements:

• Minimum high school diploma/GED with 1 year working knowledge of GMPs and related Quality System processes is required.

• Employee is required to have a high degree of accuracy and attention to detail; proofreading skills are required.

• Proven oral and written communication skills, proficient interpersonal skills, and the ability to train personnel on operating a computerized system, are required.

• Good organizational skills are required

• Working knowledge of Microsoft Office (especially Microsoft Excel and Microsoft Word)

• Previous experience with an electronic document management system is highly desirable

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.