Seattle Genetics
Quality Information Systems Administrator
Quality - Bothell, Washington
Description
Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Summary
This position is responsible for supporting the Quality department by ensuring that systems are operational and GMP compliant where required. Management activities of systems may include administrative tasks, maintaining system security, end user training and issue identification and trouble shooting. May provide other technical consulting support for the Quality Information Systems department.
Responsibilities:
- Responsible for administration of on-premise and hosted software solutions. Manage changes to systems and interact with Quality personnel to improve process and troubleshoot issues within the systems.
- Ensure software solutions meet service level agreements with end users both internal and external.
- Ensure software solutions are inspection ready.
- Assist with creating system validation documents including authoring technical requirements, report specifications.
- Assist with validation testing.
- Perform user training as needed.
- Assist in creating/maintaining SharePoint department sites.
- Develop and maintain SOPs and ensure documents reflect current practices and are consistent across documents.
- Serve as liaison with IT.
Qualifications:
- This position requires an individual with previous experience in the biotech/pharma or medical device industry.
- 3 - 7 years experience performing the duties and responsibilities listed above.
- Knowledge of the functions and capabilities of data computing.
- Experience administering validated software applications.
Preferred:
- Experience implementing, configuring and administrating software solutions in a regulated industry.
- Experience working in SharePoint Skill in both verbal and written communication.
- Knowledge of CFR and GCP/ICH requirements.
- Excellent communication and organization skills.
- Ability to proactively plan, organize and function with minimal oversight.
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Apply:
Seattle Genetics
Seattle Genetics is an Equal Opportunity Employer
Submitted: 11/16/2018
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