Senior Associate, Document Control

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Senior Associate, Document Control role is responsible for coordinating activities related to the electronic and physical record documentation, training processes and systems and administering associated SOPs and business processes that ensure compliance with established company and industry requirements. Essential Functions Support the implementation and administration of electronic and physical record documentation processes and systems, including: Support development of procedures, work instructions, training materials/job aides, etc., describing electronic documentation system processes and use of the electronic Document Management System. Serve as the document control reviewer and/or approver on documentation managed through the electronic Document Management System, ensuring documents and records comply with established procedures and requirements, appropriate functional area representatives are involved in the review and/or approval and training information is accurate, complete and appropriate training groups are assigned. Create, maintain, and distribute electronic document templates supporting controlled document, validation, and/or study related document development. Conduct training on use of document control templates, as needed. Ensure appropriate representatives receive notification and ensure proper distribution of approved and/or effective documents. Support in the implementation and execution of the official controlled document process through creation of official controlled copy binders to guarantee current documents may be accessed and retrieved, as needed, and ensuring appropriate representatives receive notification upon Controlled Document implementation, retirement, or obsoletion. Distribute official documents to internal and external customers, as needed. Proactively monitor and execute the document periodic review process, coordinating with appropriate functional area representatives to ensure documents are reviewed within the specified timeframe. Receive and archive/file executed quality related documentation and records (physical records) in a secure documentation area. Control access to documentation area(s) and track document and record submission and removal activities. Create, assign numbers to, and track the issuance, closure, and reconciliation of logbooks and laboratory notebooks, as needed. Maintain quality logbooks, as required, in accordance with appropriate procedures. Provide document system support and guidance to internal customers and expertise on document content and effective document design to authors. Support administration of GxP Training management processes and systems, including: Create electronic training profiles for new employees in accordance with submitted training requests, or as instructed by management and/or appropriate functional area representatives. May conduct other administration activities for the GxP Training department, as assigned. Identify opportunities for enhancing the overall Quality - Document Control program, process, and system, and seek input on proposed strategies and/or processes to facilitate continuous program. Support internal and external audit and inspection activities through retrieval and provision of requested documents and data in a timely manner. Perform other related duties, as assigned. Education & Experience High school diploma or equivalent with 5+ years of relevant document control experience required; or Bachelor's Degree with 3+ years of relevant document control experience required Experience in a GMP regulated Biologics or Pharmaceutical environment preferred. Knowledge, Skills,