QC Systems Specialist 1

Job Titles: QC Specialist III-Documentation
Job Duration: 8 Months on W2
Job Location: Portsmouth, NH

Job Description:
Summary:
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.

Key Accountabilities
" 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's DI policies, guidelines and procedures
" Perform other duties as assigned.

Qualifications
Associate s degree Science
A combination of education and years of experience will be considered.

Work Experience
Minimum 2 years editing and/or regulated industry experience

Agility
" Demonstrates ability to learn and use the knowledge to drive improvements.
" Ability to change directions often and work with different internal and external customers
" Understands priorities and acts in a manner to support the business units
" Shares ideas to improve and streamline activities
" Works with internal customers to achieve results
" Listens and respect ideas from others
" Seeks to understand customer needs through meetings, to deliver high quality results
" Works with Technical Transfer teams to drive results
" Works to enhance work to ensure customer s needs are met.
" Consistently follows up on all projects to ensure deadlines are met
" Ensures quality of work with demands of the position is met
" Have a strong technical writing ability to support specifications and reports
" Drives assignments to completion.
" Ensuring the highest standard of quality in all aspects of the job.

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