Coordinator, Document Control (Contract)
Quality | Newark, CA | Temporary
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated individual to join us as a Document Control Coordinator in our Newark, CA facility for a 6+ month contract opportunity. You will work with the Quality team in supporting our efforts in this exciting new area of allogeneic CAR T cell therapy.
The Document Control Coordinator oversees the creation, revision, issuance and tracking of controlled documents used to support the construction and qualification of Allogene’s manufacturing facility and associated testing laboratories, and additionally support documentation needs for our other sites as needed. Mature professional capable of working independently and in a team setting. Continually evaluates opportunities for improvement to increase efficiency and effectiveness, while ensuring compliance to internal processes, regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to effectively prioritize based on criticality.
- Client support which consistently results in favorable project results and client satisfaction.
- Works directly with clients to create, revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.
- Processes, distributes, and maintains controlled documentation (i.e., SOPs, forms, validation documents, logbooks, etc.) using Veeva QualityDocs Electronic Document Management System.
- Completes document control activities when processing documents per standard checklists, e.g. ensures correct templates, format, punctuation are used, and all document control requirements are met.
- Maintains/improves tools, checklists and SOPs which define document control team standard processes.
- Files, tracks and archives GMP documentation; some scanning for electronic record retention.
- Performs other duties or assignments as required by management.
- High School Diploma and minimum 3 years’ experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries in a Document Control position, including the revision, issuance and tracking of Standard Operating Procedures (SOP), Forms, Validation documents, Specifications, etc.
- Excellent computer skills and working knowledge of Microsoft suite of products, including Word, Excel, and Outlook. Proficient in word processing using Word.
- Experience with Veeva QualityDocs Electronic Document Management System from Document Control perspective
- Experience with Adobe Acrobat, Visio, Adobe Sign, DocuSign preferred
- Strong organizational skills and attention to detail a must.
- Excellent interpersonal skills, works well with others
- Excellent telephone skills and ability to communicate via email
- Filing experience
- Exposure to validation process and documentation, Process Development (PD) and electronic validated computer systems a plus
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.