| Urgent Need :: Validation IT/QC Analyst at Houston, TX | Onsite Role | at Houston, Texas, USA |
| Email: [email protected] |
| Hi, Please find job description below; VISAS-No-h1b TITLE- Validation IT/QC Analyst ( more of IT role in lab environment) LOCATION- Houston, TX ONSITE DURATION- 6+ MONTHS CONTRACT TO HIRE INTERVIEW- telephonic and WebEx Job Summary: S upport ongoing through technical assistance as it relates to computerized systems and infrastructure for QC systems. Provide technical support to internal customers to ensure that systems are designed, implemented, operated, and maintained per site needs. Key Responsibilities : Lead the QC application implementation and integration projects for the Houston Site. Procure, configure, and maintain any computers, instruments, and equipments related to the QC labs. Execute test scripts (design, execution, simulation, etc.) with support and guidance from the supervisor. Work together with customer, vendor, local and global teams to configure the application adapting to the local needs, and document any application deliverables. Configure instruments and devices related to the implementation of QC systems and applications. Author of Operational Handbook, User Management, Periodic Reviews/Maintenance and Disaster Recovery SOPs. Responsible for the QC applications support (including system periodic reviews). Assist the Quality department with deviation investigations. Performs OIS review/approval of deviations. Participate in RCAs as OIS representative. Assist with the completion of CAPA actions. Provide on-site support and training to system users. Provide after-hours support as needed to resolve issues outside of normal business hours. Review/revise OIS and manufacturing-related, SOPs, Functional Specifications, and work instructions, as a result of CAPA, equipment/process changes, error prevention activities, etc. Utilize system documentation to solve complex problems. Contribute to the design and implementation of new applications/ solutions related to the integration of QC instruments to QC applications/systems to enable data transfer. Understand and comply with 21 CFR Part 11 regulations. Qualification: Certificate/ ASC/ BS in science-related discipline preferred and 5+ years experience in the biotech work environment. Prior knowledge and experience of Automation/MES systems development and integration are preferred. Excellent Communication Skills. Ability to effectively communicate via writing and oral communication at all levels. Express ideas effectively in individual and group situations (including non-verbal communication). Ability to communicate with internal and external personnel. Ability to secure relevant information and identify key issues and relationships from a base of information. Relate and compare data from different sources, identify cause and effect relationships, and propose solutions. Regards, Vijay Kumar | Lead Recruiter Trail Blazer Consulting LLC | Astoria, NY 11105 Office: 914-650-4600 Ext: 148 Keywords: information technology New York Texas |
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| Fri Dec 29 20:43:00 UTC 2023 |