Quality Assurance - Document Management Specialist

Quality Assurance - Document Management Specialist

Job Description:
• Reports to the Manager of Quality Systems and is responsible for the control, review, maintenance and issuance of Quality Documents such as; Batch Records, Certificates of Analyses, Standard Operating Procedures, Test Records, Notebooks, Training Records, Technical Transfers, Subcontractor Reports, Equipment Qualification Documents, and Regulatory Correspondences for VaxInnate.
•These documents will be treated as critical as most may be subject to Regulatory review.
•In addition, the incumbent provides Company, Quality and Regulatory guidance’s, while working under minimal supervision supplying support to VaxInnate Document Systems by providing a uniform, traceable and consistent process for controlling all documented information vital to Quality Operations.
•The Document Management Specialist ensures the traceability and organization of all documents related to compliance related activities.
•An understanding of guidelines, regulations and documentation requirements specific to GXP practices as well as excellent technical writing skills are helpful.
•Superb organization skills as well as a high level of attention to detail are required.
REQUIREMENTS
Job Requirements:
(Primary Responsibilities)
The Document Management Specialist is the primary point of contact for the initiation, review, editing and tracking of all controlled documents as well as managing the flow of controlled documents from creation to storage.

Other responsibilities include the following;

•Assist in facilitating document review to ensure compliance with established policies, regulatory guidelines, and applicable regulations.
•Support/identify improvements to the Quality System - Document Control Process.
•Provide assistance in the development and review of VaxInnate Quality Documents.
•Guide, advise and inform user personnel of Document Control Processes.
•Edit, Review and maintain existing Quality System Documents
•Participate in streamlining and expediting the review and approval process for all document related to VaxInnate Quality activities.
•Assist to create and maintain VaxInnate Document Control Management Systems.
•Maintain controlled documents and records for archive storage.
•Other QA duties/responsibilities as defined by management.

Education/Skills and Experience Requirements:
•Bachelor’s degree, preferably in the Life Sciences or industry experience equivalent.
•2-4 years experience in pharmaceutical/biotech industry, cGXP, regulatory environment or a highly organized and/or structured industry equivalent.
•Advanced knowledge in Microsoft Office (MS-Word, MS-EXCEL, MS-Access) software.
•Excellent verbal and written communication skills and the desire to work very closely with scientifically dynamic personnel are essential.