Quality Systems Administrator III
- Employer
- Fate Therapeutics
- Location
- San Diego, CA
- Start date
- Jan 27, 2022
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
Responsibilities
- Day to day management of the company’s electronic systems related to quality, including, but not limited to: oSystem administrator for all electronic systems such as Veeva QualityDocs and Veeva QMS
- Write, revise, and review documents relating to Quality Systems
- Proactively maintain an understanding of regulations and best practices for a robust Quality Management System e.g. FDA, USP, ICH, etc.
- Perform other Quality related duties as assigned
oSupport validation and implementation of electronic systems, including eQMS and LMS
oTraining end users and providing ongoing support to electronic systems
oTroubleshooting and maintenance for systems, including managing software updates, change control, etc.
oSupport daily management of the eDMS (Veeva Vault QualityDocs) and other systems as they are implemented
oSourcing, researching, and presenting options for LMS, eQMS, and any other electronic system to leadership to gain approval
Qualifications
- Bachelor’s or associate degree in a relevant scientific discipline and a minimum of 3 years of relevant quality systems experience in the Pharmaceutical/Biotechnology industry
- Strong experience in system administration of electronic quality management systems preferably in Veeva Vault and ComplianceWire
- Strong background in computerized systems such as Veeva Vault, MasterControl, ComplianceWire, LIMS, Audit Utopia, etc., and Microsoft Office suite
- Strong attention to detail, team orientation with excellent written and oral communication skills
- Able to work independently and prioritize tasks in a fast paced and dynamic environment
- Experience preparing and reviewing cGMP documentation
- Working knowledge of 21 CFR Part 11, 211 and 210, FDA/ICH guidelines, and industry/technology standard practices including GMP, GCP, and GTP
Working Conditions and Physical Requirements
- May require occasional evening and weekend work.
- Full-time onsite work at company’s headquarters in San Diego.
- Frequently required to work on a computer up to 8 hours a day.
- Occasionally required to stoop, kneel, and lift up to 50 pounds.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
Company
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
- Website
- http://www.fatetherapeutics.com/
- Phone
- 858.875.1800
- Location
-
12278 Scripps Summit Drive
San Diego
California
92131
United States
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