Document Control Specialist - MGI PHARMA - Bloomington, MN

Document Control Specialist - MGI PHARMA - Bloomington, MN

 

Position Overview

Associate in this position will provide document management support for the Lead Compliance Specialist (this is the current title).  In this role the associate will perform miscellaneous GXP documentation related activities.  This position will serve as the Quality Assurance representative for commercial quality activities at the MGI PHARMA Bloomington site.

 

Critical Performance Areas

1.  Assist with the development and/or revision, generate and provide for the maintenance of all types of GMP associated documents

2.  Maintain databases relevant to GMP associated documents

3.  Manage the GMP associated document control areas including the historical/archived document area

4.  Maintain training records for all site associates conducting or supporting GXP activities

 

Essential Job Functions

? Position will assist with coordinating the final review, revision, approval and issuance process for all GMP associated documents

? Position will assist with the maintenance of both paper and electronic GMP associated document files

? Position will assist with the preparation and delivery of GMP associated documents for training

? Position will independently maintain current versions of site initiated GMP associated documents on the MGI PHARMA intranet site

? Position will assist with the scheduling and setup of the on-site GMP training program

? Position will conduct new employee orientation in the QA function and arrange for QA-related training

? Position will evaluate and grade written GMP knowledge assessments

? Position will assist with the coordination of document shipments for client reference or for off-site storage and/or retrieval

? Position will prepare GMP associated documents for scanning into the Disaster Recovery program and will perform the scanning as required

? Position will maintain original training record documentation for all site associates conducting or supporting GXP activities

 

 

Requirements

? Must be able to accurately and consistently follow written and verbal direction

? Must be able to communicate effectively verbally and in writing

? Must be able to think independently to develop solutions to growth-related issues that are outside company directives

? Must have demonstrated ability to organize documents

? Must be proficient with MS Word and Excel software

 

 

 Other Desired Skills/Abilities

? Must be detail oriented

 

 

NOTE:  This job description is not intended to be all-inclusive. Associate may perform other duties to meet the ongoing needs of the organization.

 

 

 

 AN EQUAL OPPORTUNITY EMPLOYER