GLP Archivist (19-00681) – WA – Bothell

Short Description:
This position reports to the Senior Manager, GLP Compliance and is responsible to implement, maintain and manage the GLP and non-GLP document archives in compliance with applicable regulatory requirements and Company SOPs. 
•           Revise and develop archive SOPs (and forms) to ensure archival activities comply with regulatory requirements
•           Archive completed GLP and non-GLP study raw data, protocol, reports, electronic data/records, and any other relevant documents following the appropriate cataloging system based on current SOPs
•           Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports, for example, during a FDA inspection
•           Ensure that storage conditions are maintained to prevent deterioration of documents or samples for the duration of their retention
•           As required, collaborate and coordinate with study director or delegate for the transfer of study data, documents and/or samples to off-site archival locations
•           Ensure that only authorized personnel have access to the archive in accordance with governing SOP GLP regulations
•           Ensure materials retained in the archive are appropriately indexed for expedient retrieval
•           Create and manage the inventory of onsite and offsite storage
•           Perform data entry of study records into the archive database
•           Collaborates directly with respective departments regarding disposition of archived materials
•           Assist in identifying and implementing an electronic archival solution. Develop procedures for electronic archival
•           Other responsibilities as assigned
Skills and Knowledge:        
•           Knowledge of GLP regulatory requirements e.g. 21 CFR Part 58, OECD etc.
•           Ability to handle changing priorities if needed in a fast-paced environment
•           Proficient in computer skills; departmental database (Access), MS Word, Excel, Adobe, database applications
Ability to work on a team or independently & detail oriented
Excellent written and verbal communication skills
Minimum Qualification(s):
Bachelor's degree or equivalent with 2-3 years of experience in pharmaceutical/ biotechnology industry. Experience in GLP/non-GLP archiving activities.
Experience with electronic archival systems is preferred.
Up to 10% travel time, if required

Source: Job Diva – Job Listing

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