GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
Ensures appropriate processing, revision and control of quality documents in the electronic DMS, monitors and responds to Document Control mailboxes, provides internal user/customers support by responding to questions and inquiries, training, and coordination of workflow activities throughout the document lifecycle. Responsible for issuing, receiving and archiving of quality records processed through the QA Document Control Center. Provides timely and accurate document support to all GMP functions at Immunomedics facility.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES) • Oversight and monitoring of document revision workflows and other tasks associated with Documentation Control.
• Assist users in all aspects of the document lifecycle using Veeva Quality Document System.
• Formatting and editing documents to ensure alignment with established templates.
• Ensuring appropriate reviewers and approvers for document revision.
• Review documents to ensure appropriate documentation of revision history and associated quality records including CAPA, Change Controls, and Investigations.
• Alignment of dates for implementation and training in accordance with department procedures and corporate expectations.
• Oversight and monitoring of periodic review activities • Monitors and responds to Document Control mailboxes • Coordinate processing of all quality records issued, received and archived through the QA Control Center; Document processing includes verification of receipt, scanning, and handling & storage of all Quality Records.
• Issuance of manufacturing batch records, controlled form copies, logbook and laboratory notebooks, and executable protocols.
• Maintain document storage rooms to ensure accurate archive and easy retrieval.
• Retrieve requested records, including logging out records and following up to ensure prompt record return.
• Follow up to ensure prompt return and reconciliation of controlled forms and logbooks.
• Prioritize tasks based upon department objectives and business criticality.
• Provide training and support for other document control or control center personnel • Prepare quality metrics and reports as required.
• Author revisions to document control procedures, forms, and templates as required.
• Perform other duties as required and available for overtime
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES) • Advanced application competency, including Microsoft Word, Excel, Visio, and Outlook • Excellent reading and writing skills.
• Excellent organization skills and attention to detail.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL) • Work experience in regulated industry (biologics, pharma, medical device) • Work experience with EDMS in a document control role. Veeva preferred, but not required.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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