BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Document Management Specialist to work for a leading San Diego biotechnology company.
Document Management Specialist
Responsible for the administration of the document management system(s) (EDMS) and manage the migration of documents from Qumas to Documentum. This position will also be responsible for the management of the GXP training program, administration of GXP Standard Operating Procedures (SOPs) and management of development department documents.
Principal Duties and Responsibilities
Responsible for the administration of the EDMS, as well as the development and maintenance of EDMS procedures and training documentation.
Responsible for document management including electronic and hardcopy records (RA, QA, and Clinical).
Manage the GXP training program, including setting up training webinars, annual reviews of training files and tracking of training requirements and completion.
Manage the GXP SOP system including processing SOPs in the EDMS and ensuring periodic review of SOPs.
Perform other duties as assigned.
BA/BS or an equivalent combination of education and related experience.
Minimum 3 years of experience in the pharmaceutical or biotechnology industry or equivalent.
Working knowledge of GXP regulations.
Familiarity with GXP documents and associated controls.
Strong computer skills and expertise, including experience using EDMSs, Microsoft Word, Excel, and PowerPoint proficiency.
Excellent organizational skills and attention to detail.
Effective oral and written communication skills.
Effective team participation skills.
BioPhase Solutions - 22 months ago
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