Responsible for executing and maintaining key documentation functions within IRIX Quality Systems. Assist Director of Quality and Quality Assurance Specialists with maintaining the IRIX Quality System procedures and records.
Control and execute the filing and storage of executed project documentation for R&D non-GMP and cGMP projects
Assign, track, log in and reconcile laboratory log sheets
Manage the on-site and off-site (Iron Mountain) storage of all IRIX documents from all departments
Maintain remote collections of IRIX controlled documents such as SOPs, specifications and Analytical Procedures (AP) with new issuance and updates while reconciling and destroying old versions. Update and issue Tables of Contents for same.
Support quality certification programs for suppliers and vendors through documentation management and communications.
Assigns deviation report, change control, OOS, and PQI numbers from logbooks and the database.
Assists in client and regulatory audits by fulfilling and logging documentation requests.
Bachelor’s degree or associate degree in business or scientific discipline, equivalent experience in a related position will be considered. Experience in a quality or regulatory documentation position desired (medical, legal, environmental records and reports). Practical knowledge of Microsoft Word, Excel, PowerPoint is required. Working knowledge of Microsoft Project and controlled databases is a plus
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