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Manager, Qc Systems And Services
Company | Bristol Myers Squibb |
Address | Bothell, WA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-10-11 |
Posted at | 8 months ago |
Working with Us
- Advanced degree preferred.
- Bachelor’s degree or equivalent required, preferably in Science.
- 4-6 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience in systems deployment.
- Demonstrated ability to establish processes between multiple groups within Cell Therapy
- Demonstrated technical writing skills.
- Advanced knowledge of LIMS, ELN and/or Cellular Therapy business process highly preferred.
- High problem-solving ability/mentality, technically adept and logical.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Perform data verification, data review and review of GMP documentation for multiple systems (general and complex) and/or products.
- Responsible for owning a process within the QC Systems organization. West Coast Site Lead would be responsible for CELabs west coast operations.
- Master Data Delivery within the timelines set forth by the SLA/Business
- Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
- May represent the department in regulatory inspections (internal and external audits).
- Responsible for Site Issue and Risk Management with respect to CTO systems under the Network QC umbrella.
- Train and mentor others on multiple QC system modules, processes and procedures.
- Site Coordination of CELabs Go-live activities and business workstreams.
- Subject matter expert \ in a system process, supporting system deployment across CTO.
- Drives/Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- Cross trained on business and technical aspects of the QC Systems organization.
- Anticipate and perform complex troubleshooting and problem solving independently.
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