The Document Control Administrator I is responsible for administering corporate document control processes for all computerized and hard copy files, which may include one or more of the following tasks:
Assists in compiling corporate filing documents and maintaining computerized files to support all documentation systems, including controlled documents, technical documents, master equipment, manufacturing and CMO.
Assists the review and revision of procedures, specifications and forms.
Updates logs, databases and catalogues.
Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
May assist in conducting training of department processes and electronic document management systems.
Issue / Review Master Batch Records
Assist in the development and maintenance of document filing systems for storage of controlled documents
Issuance of laboratory notebooks, and the creation and issuance of logbooks
Maintain history files for all SOP's, certificates of analysis, specifications and other documentation as necessary
Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Normally receives no instructions on routine work, general instructions on new assignments.
Bachelor’s degree in a scientific discipline or equivalent.
Proficient in MS Office applications.
Typically 2 years related experience in cGMP/FDA regulated industry.