Quality Document Clerk (Contract)
Quality | Newark, CA | Contract
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.
Allogene is seeking a Contract Quality Document Clerk to support our Documentation Management operations. The primary goal of this project is to assist in setting up and maintaining a paper-based filing system for QA documents. This role will be a hands-on reporting to our Senior Manager, Document Management, Learning and Development and onsite at both our headquarters in South San Francisco and manufacturing facility in Newark, CA. This is a 1-2+ month contract opportunity.
Responsibilities include, but are not limited to:
- Assist in creating, organizing, and maintaining paper-based QA documents and records system.
- Manage, track, and store a variety of electronic and hardcopy documents and records including GMP, validation, commissioning, etc. documents through a file and folder naming structure.
- File, track, and archive documentation in physical, some scanning for electronic record retention
- Checking for accuracy and editing files
- Retrieve files as requested by employees and clients
- Manage the flow of documentation within the organization
- Maintain confidentiality around sensitive information
- Performs other duties or assignments as required by management.
Position Requirements & Experience:
- High School Diploma and 1 to 2+ years’ experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries
- Filing experience
- Proficient computer skills and working knowledge of Microsoft suite of products, including Word, Excel, and Outlook.
- 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
- Candidates must be authorized to work in the U.S.
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.