QC Sample Management Scientist
- Expired: July 25, 2022. Applications are no longer accepted.
Title: QC Sample Management Scientist
Location: Seattle, WA
Start date: ASAP
+ Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines in order to ensure timely CoA/CoT (Certificate of Analysis/Certificate of Testing) generation for Cell Therapy vector products
+ Conduct weekly meetings with Contract Test Labs (CTL) to provide testing forecasts, generate sample submissions, provide shipping details to CMOs, track testing status and be point of contact for any testing questions or problems
+ Regularly communicate testing and CoA status to internal BMS partners via Sharepoint/Smartsheet testing tracker, and meeting minutes from weekly CTL meetings
+ Work cross functionally to provide a single point of contact for QA sample management to internal teams and external manufacturing partners
+ Effectively communicate issues, risks and proposed solutions within the organization
+ Provide communication, support, and guidance to manufacturing partners and within the QA CMO team
+ Create and revise Standard Operating Procedures as needed
+ Other duties (such as facilitate tracking of quality records etc.) as assigned
+ AS in relevant scientific discipline, or 3 years' experience in Biotherapeutics/Biomanufacturing QC/QA, or an equivalent combination of education and experience.
+ Strong organizational skills, including ability to follow assignments through to completion
+ Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects
+ Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-function teams
+ Detail-oriented with demonstrated applications in problem solving
+ With moderate oversight from manager, think strategically and understand global impact of decisions
+ Preferred Qualifications:
+ Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
+ Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered.
+ Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management
+ Knowledge of applicable FDA/EMA regulations in the biotechnology industry
+ Experience managing external suppliers and other supply chain issues
+ Experience with Quality Systems (change control, deviation and investigation) is a plus.
System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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