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
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Support the implementation and administration of electronic and physical record documentation processes and systems, including:
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Support development of procedures, work instructions, training materials/job aides, etc., describing electronic documentation system processes and use of the electronic Document Management System.
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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.
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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.
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Ensure appropriate representatives receive notification and ensure proper distribution of approved and/or effective documents.
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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.
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Distribute official documents to internal and external customers, as needed.
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Proactively monitor and execute the document periodic review process, coordinating with appropriate functional area representatives to ensure documents are reviewed within the specified timeframe.
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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.
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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.
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Provide document system support and guidance to internal customers and expertise on document content and effective document design to authors.
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Support administration of GxP Training management processes and systems, including:
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Create electronic training profiles for new employees in accordance with submitted training requests, or as instructed by management and/or appropriate functional area representatives.
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May conduct other administration activities for the GxP Training department, as assigned.
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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.
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Support internal and external audit and inspection activities through retrieval and provision of requested documents and data in a timely manner.
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Perform other related duties, as assigned.
Education & Experience
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High school diploma or equivalent with 5+ years of relevant document control experience required; or
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Bachelor’s Degree with 3+ years of relevant document control experience required
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Experience in a GMP regulated Biologics or Pharmaceutical environment preferred.
Knowledge, Skills, & Abilities
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Able to multitask across multiple functional areas, is timeline focused and flexible in in their work scheduling to meet the demands of a multi- product bio-pharmaceutical company
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Excellent verbal and written communication skills
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Able to communicate effectively across the entire ImmunityBio organization on matters related to documentation and learning management systems
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Able to prepare written communications with clarity and accuracy
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Must be able to work independently with ability to complete routine tasks with little or no supervision.
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Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, work practices, and project timelines.
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Must be proficient in Microsoft Office (Excel, Word, Access, Power Point, Visio) and Adobe Professional software.
Working Environment / Physical Environment
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This position works on-site in El Segundo, CA.
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Light to moderate lifting is required (up to 40 pounds).
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Ability to sit at a computer terminal for an extended period of time.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.
$34.75 (entry-level qualifications) to $38.25 (highly experienced) per hour
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
