QC Systems Specialist 1

The Documentation Specialist assumes responsibility for QC chemical Raw Material Specifications. The majority of this work is conducted through Document Management System (DMS) and Laboratory Information Management System (LIMS). The employee should also have knowledge of compendia (USP, EP, etc), computerized management systems, Microsoft Suite, and cGMP awareness to support others within the team and QC. The expectation is to ensure full accuracy and functionality of all raw material specifications used to support site production.

Responsibilities

• Manage updates to specifications that are requested via compliance record, management request, or any other point of entry.
• Collaborate closely with Raw Material Scientists and Coordinators to provide useful testing specifications.
• Provide clear communication to cross functional stake holders connected to any compliance record as well as member s of the raw materials team to ensure specification changes are being accurately and effectively executed.
• May own specification documents as well as relevant SOPs and Wis.
• Apply Data Integrity principles in all aspects of work, in compliance with client DI policies, guidelines and procedures.
• Perform other duties as assigned.

Requirements:

• Associate's degree.
• A combination of education and years of experience will be considered.

Work Experience:

• Minimum 2 years editing and/or regulated industry experience.

Skills:

• Advanced level in MS Suite applications, particularly Word and Excel.
• Excellent proof reading/editing.
• Experience with document management systems (DMS)/document control practices.
• Experience with document change management.
• Experience in technical writing (protocols, reports, specifications and methods).
• Coherent and effective interpretation of written and verbal instructions.