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Process, compile, review, and maintain designated cGMP documents and other master documents.
• Maintain master and control records
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Enforce procedures governing document management
• Conduct training on document management procedures, as applicable
• Perform non-technical review of documents
• Word process documents as required
• Respond to requests (i.e., document information copies, problem solving, and general information pertaining to document management)
• Issue Batch Production Records, issue labels for study kits and vaccine shipments, issue final product labels and reconcile returned labels
• Coordinate periodic review of documents
• Write/revise document management procedures, as applicable
• Normally receive no instructions on routine work and general instructions on new assignments
• Perform other reasonable, related business duties
• 2-5 years related experience in documentation in a regulated environment or equivalent
• Sound organization skills and attention to detail
• Effective written and verbal communication skills
• Strong grammatical skills
• Ability to work well as a team player or individually
• Ability to multi-task effectively
• Working knowledge of Microsoft Word and Microsoft Excel required; Microsoft Access preferred
• Bachelors degree or equivalent experience
We offer a competitive compensation package along with outstanding benefits.
For confidential consideration, please
a resume with a cover letter and salary
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.