Job Description

● Facilitates the full life cycle of master documents (not limited to SOPs, batch records, test methods, protocols, reports, specifications, etc.). ● Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (meta data), monitors document status and approval notifications, distributions, and archiving. ● Interacts with internal customers to provide customer service for document formatting, routing, issuance, copying, scanning, etc. ● Facilitates the archival of GMP documentation and records. ● Prepares and inspects documents for scanning operations, scans and re-assembles documents. ● Coordinates the transfer of records to / from long term storage facilities; manages records classifications and storage location in the Record Management System (RMS). ● Ensures records are maintained according to regulatory requirements. ● Supports document retrieval for internal and external audits.

Requirements

● Bachelor/Master degree in related field (science), or equivalent work experience and 1+ years of experience in QC. ● Excellent oral and written communication skills. ● Exhibits strong attention to detail. ● Strong organizational skills required. ● Displays an emerging ability to manage client expectations. ● Ability to manage both day-to-day operations as well as project work in a fast paced environment.

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