Document Control Specialist

BASIC PURPOSE

This position manages, organizes, and secures quality and regulatory documents to ensure strict compliance with Current Good Manufacturing Practices (cGMP) within The Mentholatum Company. This includes creation, review, publication, and archive of electronic and paper cGMP documents. Another core responsibility is performing the functions of system administrator for the document management system, Singlepoint and other quality related software for consumer complaints and data collection systems. This requires use of change control process for user access, system changes, and troubleshooting user problems. The position supports software qualification and/or validation activities pertinent to cGMP related software. Assist with identifying, developing, and qualifying new modules or features of the Singlepoint document management system. The position requires that appropriate procedures are followed through knowledge of good manufacturing practices, safety awareness, awareness of and compliance with regulatory guidelines (cGMP, GLP).

POSITION RESPONSIBILITIES

• Document Management: Create, publish, review, and archive electronic and paper cGMP documents. This includes but is not limited to material control records (specifications, testing results, Standard Operating Procedures (SOPs)), test methods, change controls, testing documentation, and qualification/validation documents.
• System Administrator: Perform the functions of system Admin. for quality software applications: Singlepoint, Trackwise (customer complaint), Tutela (temperature monitoring), and Shimadzu Lab Solutions (test data) by managing user access through change control process, assist with resolution of system problems, assist with software qualification/validation by creating necessary documents and execution of test scripts as needed.
• Maintain Singlepoint related SOPs and user documents based on latest version in the production environment. Create and disseminate training material related to new features or enhancements to all TMC users.
• Maintain Quality Department training matrix which includes QA, QC, and Microbiology groups. This includes organizing completed training documents and updating the training matrix spreadsheet.
• Coordinate and prepare necessary documentation for the purpose of completing analytical testing of material and product by third party testing laboratories.