Duties:
Job Purpose
· The Document Controller supports the development and maintenance of quality processes related to document management for global Quality groups as well as EDGE projects on an as requested basis.
· This role oversees the document management process to provide assurance that all documents are suitability reviewed, implemented and approved and comply with cGMP, legal, regulatory requirements, and Seqirus Quality Manual requirements by performing document control activities using the both the legacy and incoming Enterprise Document Management Systems (EDMS).
Major Accountabilities
· Perform Document Control activities within legacy and incoming EDMS, such as verification of form completion, troubleshooting workflows and report generation.
· Format and edit documents, including Standard Operating Procedures, Specifications, Controlled Forms, and Policies that supportGMPoperations and comply with cGMP and FDA guidelines, and additional quality standards addressed in Seqirus' Quality Manual.
· Assist investigating deviations and CAPAs related to the legacy and incoming EDMS.
· Support the development and continuous improvement of Global Quality Systems document management system SOPs and Work Instructions for the new EDMS.
· Ensure adherence to the Standard Operating Procedures that govern the use of the legacy EDMS.
· Report Quality KPIs to management as requested.
Skills:
· 2+ year's experience as a document controller strongly preferred.
· 2+ year's experience in QA function or pharmaceutical manufacturing preferred.
· Must be highly skilled in Microsoft Word, Excel and experienced in PC's and databases.
· Must be able to proof work and identify non-standard format or wording, and errors within documents.
· Must have excellent communication skills and strict attention to detail.
· Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
Education:
Bachelor's degree or equivalent work experience
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Last updated on Jul 26, 2017